GSPR

1.
Purpose
The purpose of this document is to demonstrate conformity to the General Safety and Performance Requirements as they apply to [Product
Name].
2. Scope
This General Safety and Performance Requirements (GSPR) Checklist has been created for the [Product Name / Family Name] detailed
below.
Device Model Number(s) Device Name Description
3. Applicable Standards / Documents
List all related standards:
Table 1. Standards, Common Specifications, and Procedures References

(list standards and common specifications (includes title and date) and procedures (title and revision) as referenced within this GSPR)
[Rows should be added or deleted as required]
Quality Standards Title
[Standard number / version]
Risk Management Standards Title
Device Specific Standards Title
Clinical Standards Title
Biocompatibility Standards Title

Labeling Standards Title
Packaging Standards Title
Sterilization Standards Title
Environmental Control Standards Title
Table 2. Documents References

The table below lists the references used to demonstrate compliance to the GSPR.
[Rows should be added or deleted as required]
Location in STED Document
Ref Document Type Document Number (Rev. #) Document Title
No. XXX
[Appendix]
1 Quality [Appendix]
[Appendix]
[Appendix]
2 Risk Management
[Appendix]
Design
3 [Appendix]
Verification/Validation
Qualification/Process
4 [Appendix]
Validation
5 Clinical [Appendix]
Post-Market
6 [Appendix]
Surveillance
7 Labeling [Appendix]
8 Biocompatibility [Appendix]
Packaging & Shelf Life
9 [Appendix]
Validation
10 Sterilization [Appendix]
11 Usability
4. General Safety & Performance (GSPR) Checklist
Column 1 Column 2 Column 3 Column 4 Column 5

Annex I - General Safety and Performance Applicability Standards, Common Methods used to demonstrate Location in
Requirements (Yes or N/A) Specifications, conformity (Justification, Technical
Procedures applied by validation and verification) Documenta
*If N/A provide manufacturer with each applicable GSPR tion (TD)
justification in
Column 4 (for revision, see (see Table 2 for document
Table 1 of Section 3) references in Section 3)
Chapter – I General Requirements
1. Patient safety and intended

performance
1. Devices shall achieve the  User Training, Usability
performance intended by their Studies, See Table 2
manufacturer and shall be designed  Risk Management File of Section
and manufactured in such a way  Plan 3.0
that, during normal conditions of  Report
use, they are suitable for their  Benefit / Risk
intended purpose. They shall be safe  Hazard Analysis /
and effective and shall not System Risk
compromise the clinical condition or Assessment
the safety of patients, or the safety  Design FMEA
and health of users or, where  Process FMEA
applicable, other persons, provided  Software FMEA
that any risks which may be  Use FMEA
associated with their use constitute  V&V Testing
acceptable risks when weighed  Clinical Evaluation Plan
against the benefits to the patient and Report /Conclusion
and are compatible with a high level
of protection of health and safety,
justification in
taking into account the generally
acknowledged state of the art.
2. Risk reduction (As far as possible)
2. Reduce risks as far as possible  Risk Management File
means the reduction of risks as far (Plan, Report)
as possible without adversely  Hazard
affecting the benefit-risk ratio. Analysis/System Risk
Assessment
 Design FMEA
 Process FMEA
 Software FMEA
 Use FMEA
 Clinical Evaluation
3. Risk Management
3. Manufacturers shall establish, Risk Management SOP
implement, document and maintain
a risk management system. Risk
management shall be understood as
a continuous iterative process
throughout the entire lifecycle of a
device, requiring regular systematic
updating. In carrying out risk
management manufacturers shall:
a. establish and document a risk  Risk Management Plan
justification in
management plan for each
device;
b. identify and analyze the known  Hazard Analysis /
and foreseeable hazards System Risk
associated with each device; Assessment Report
 Design FMEA
c. estimate and evaluate the risks
 Process FMEA
associated with, and occurring
 Software FMEA
during, the intended use and
 Use FMEA
during reasonably foreseeable
misuse;
d. eliminate or control the risks  Risk Management File
referred to in point (c) in (Plan, Report)
accordance with the  Hazard
requirements of Section 4; Analysis/System Risk
Assessment
 Design FMEA
 Process FMEA
 Software FMEA
 Use FMEA
 Labeling
 User Training
e. evaluate the impact of  Risk Management File

information from the production (Plan, Report)
phase and, in particular, from  Post Market  Hazard
justification in
the post-market surveillance Surveillance SOP Analysis/System Risk
system, on hazards and the Assessment
frequency of occurrence  Design FMEA
thereof, on estimates of their  Process FMEA
associated risks, as well as on  Software FMEA
the overall risk, benefit-risk ratio  Use FMEA
and risk acceptability; and  Labeling (Investigator
Brochure, Patient
Guide, Informed
Consent Form,
Instructions
f. based on the evaluation of the  Risk Management File
impact of the information (Plan, Report)
referred to in point (e), if  Hazard
necessary amend control Analysis/System Risk
measures in line with the Assessment
requirements of Section 4.  Design FMEA
 Process FMEA
 Software FMEA
 Use FMEA
 Labeling (Instruction
for Use, Investigator
Brochure etc.)
 User Training
4. Risk Control
4. Risk control measures adopted by  Risk Management  Risk Management File
justification in
manufacturers for the design and SOP (Plan, Report)
manufacture of the devices shall  Hazard
conform to safety principles, taking Analysis/System Risk
account of the generally Assessment Report
acknowledged state of the art. To  Design FMEA
reduce risks, Manufacturers shall  Process FMEA
manage risks so that the residual  Software FMEA
risk associated with each hazard as  Use FMEA
well as the overall residual risk is  Labeling
judged acceptable. In selecting the  User Training
most appropriate solutions,
manufacturers shall, in the following
order of priority:
a. eliminate or reduce risks as far
as possible through safe design
and manufacture;
b. where appropriate, take
adequate protection measures,
including alarms if necessary, in
relation to risks that cannot be
eliminated; and
c. provide information for safety
(warnings/precautions/contra-
indications) and, where
appropriate, training to users.
d. Manufacturers shall inform
justification in
users of any residual risks.
5. Eliminating use error
5. In eliminating or reducing risks  Hazard

related to use error, the Analysis/System Risk
manufacturer shall: Assessment Report
a. reduce as far as possible the  Use FMEA
risks related to the ergonomic  Labeling (Instructions
features of the device and the for Use)
environment in which the device  User Training
is intended to be used (design  Usability Studies
for patient safety), and
b. give consideration to the
technical knowledge,
experience, education, training
and use environment, where
applicable, and the medical and
physical conditions of intended
users (design for lay,
professional, disabled or other
users).
6. Performance of device
6. The characteristics and performance  Risk Management File

of a device shall not be adversely (Plan, Report)
affected to such a degree that the  Hazard
justification in
health or safety of the patient or the Analysis/System Risk
user and, where applicable, of other Assessment
persons are compromised during  Design FMEA
the lifetime of the device, as  Process FMEA
indicated by the manufacturer,  Software FMEA
when the device is subjected to the  Use FMEA
stresses which can occur during  User Training
normal conditions of use and has  Shelf Life Studies
been properly maintained in  Clinical Evaluation
accordance with the manufacturer's  V&V Testing
instructions.  Clinical Evaluation
7. Transport and Storage
7. Devices shall be designed,  Performance

manufactured and packaged in such Requirements
a way that their characteristics and  Storage & Transport
performance during their intended Requirements /
use are not adversely affected Reports
during transport and storage, for  Packaging
example, through fluctuations of Requirements
temperature and humidity, taking  Packaging Validation,
account of the instructions and Including Accelerated
information provided by the and Real Time Shelf-
manufacturer. Life Studies
 Labeling
8. Risk Benefit
justification in
8. All known and foreseeable risks, and  Clinical Evaluation
any undesirable side-effects, shall be Report
minimized and be acceptable when  Clinical Risk Benefit
weighed against the evaluated analysis
benefits to the patient and/or user  Risk Management
arising from the achieved Report
performance of the device during  Risk-Benefit Analysis
normal conditions of use.
9. Risk assessment for devices listed in
Annex XVI
9. For the devices referred to in Annex If N/A, the [Product Name] is
XVI, the general safety requirements not a device without an
set out in Sections 1 and 8 shall be intended medical purpose as
understood to mean that the device, referred to in Annex XVI.
when used under the conditions and
for the purposes intended, does not
present a risk at all or presents a risk
that is no more than the maximum
acceptable risk related to the
product's use which is consistent
with a high level of protection for
the safety and health of persons.
Chapter – II Design and construction requirements
10. Chemical, physical and biological properties
10.1 Devices shall be designed and
manufactured in such a way as to
justification in
ensure that the characteristics and
performance requirements referred
to in Chapter I are fulfilled.
Particular attention shall be paid to:
a. the choice of materials and  Design Input
substances used, particularly as  Design Specification and
regards toxicity and, where Rationale for Material
relevant, flammability; Selection
 Material Physical and
Characterization
 Biocompatibility
If N/A, There is no risk of fire or

combustion associated with
the materials used in the
manufacture of the [Product
Name].
b. the compatibility between the  Pre-Clinical testing
materials and substances used  Material
and biological tissues, cells and Characterization
body fluids, taking account of  Biocompatibility
the intended purpose of the
device and, where relevant,
absorption, distribution,
metabolism and excretion;
c. the compatibility between the  Biocompatibility
justification in
different parts of a device which
consists of more than one If N/A, The [Product Name]
implantable part; does not consist of more than
one implantable product.
d. the impact of processes on  Material Physical and
material properties; Characterization
testing
e. where appropriate, the results  Material Physical and

of biophysical or modelling Characterization
research the validity of which testing
has been demonstrated  Animal Testing, if
beforehand; applicable
f. the mechanical properties of the  Material Physical and

materials used, reflecting, where Characterization
appropriate, matters such as testing
strength, ductility, fracture  Material Fatigue
resistance, wear resistance and testing
fatigue resistance;  Finite Element testing
 Fracture Resistance
testing
g. surface properties; and  Material Physical and
Characterization
testing
justification in
h. the confirmation that the device  Design Verification
meets any defined chemical testing
and/or physical specifications.  Certificate of Analysis /
Conformance
10.2 Devices shall be designed,  Packaging Validation,
manufactured and packaged in such including Sterile Barrier
a way as to minimize the risk posed testing
by contaminants and residues to  Transportation testing
patients, taking account of the  Storage testing
intended purpose of the device, and  Sterilization validation
to the persons involved in the method
transport, storage and use of the  Sterilization Validation
devices. Particular attention shall be Reports
paid to tissues exposed to those  Chemical
contaminants and residues and to Characterization
the duration and frequency of
exposure.
10.3 Devices shall be designed and  Design Verification
manufactured in such a way that Testing
they can be used safely with the  Common Technical
materials and substances, including Documentation (CTD)
gases, with which they enter into
contact during their intended use; if (For Non-Medicinal Products)
the devices are intended to The [Product Name] is not
administer medicinal products they designed to administer
shall be designed and manufactured medicinal substances
justification in
in such a way as to be compatible
with the medicinal products
concerned in accordance with the
provisions and restrictions governing
those medicinal products and that
the performance of both the
medicinal products and of the
devices is maintained in accordance
with their respective indications and
intended use.
10.4 Substances
10.4.1 Design and manufacture of devices
10.4.1 Devices shall be designed and  Aging Test Reports

manufactured in such a way as to  Material
reduce as far as possible the risks Characterization
posed by substances or particles, Report
including wear debris, degradation  Chemical
products and processing residues, Characterization
that may be released from the Reports including
device. Extractable Testing
Devices, or those parts thereof or
those materials used therein that:
– are invasive and come into direct
contact with the human body,
– (re)administer medicines, body
justification in
liquids or other substances,
including gases, to/from the body,
or
- transport or store such medicines,
body fluids or substances, including
gases, to be (re)administered to the
body, shall only contain the
following substances in a
concentration that is above 0,1 %
weight by weight (w/w) where
justified pursuant to Section 10.4.2:
a. substances which are  Material Datasheets
carcinogenic, mutagenic or toxic  Material Physical and
to reproduction ('CMR'), of Characterization
category 1A or 1B, in accordance testing
with Part 3 of Annex VI to  Finite element testing
Regulation (EC) No 1272/2008 of  CoC / CoA from the
the European Parliament and of supplier of the material
the Council1, or  Labeling
b. substances having endocrine-
disrupting properties for which
there is scientific evidence of
probable serious effects to
human health and which are
identified either in accordance
with the procedure set out in
justification in
Article 59 of Regulation (EC) No
1907/2006 of the European
Parliament and of the Council2
or, once a delegated act has
been adopted by the
Commission pursuant to the first
subparagraph of Article 5(3) of
Regulation (EU) No 528/2012 of
the European Parliament and
the Council3, in accordance with
the criteria that are relevant to
human health amongst the
criteria established therein.
10.4.2 Justification regarding the presence  CMR Justification
of CMR and/or endocrine-disrupting
substances. The justification for the
presence of such substances shall be
based upon:
a. an analysis and estimation of
potential patient or user
exposure to the substance;
b. an analysis of possible
alternative substances, materials
or designs, including, where
available, information about
independent research, peer-
justification in
reviewed studies, scientific
opinions from relevant scientific
committees and an analysis of
the availability of such
alternatives;
c. argumentation as to why
possible substance and/ or
material substitutes, if available,
or design changes, if feasible,
are inappropriate in relation to
maintaining the functionality,
performance and the benefit-
risk ratios of the product;
including taking into account if
the intended use of such devices
includes treatment of children or
treatment of pregnant or
breastfeeding women or
treatment of other patient
groups considered particularly
vulnerable to such substances
and/or materials; and
d. where applicable and available,
the latest relevant scientific
committee guidelines in
accordance with Sections 10.4.3.
justification in
and 10.4.4.
10.4.3 Guidelines on phthalates
10.4.3 For the purposes of Section 10.4.,  Hazard Analysis/Use

the Commission shall, as soon as FMEA/System Risk
possible and by … [one year after Assessment
the date of entry into force of this  Clinical Risk Benefit
Regulation], provide the relevant analysis
scientific committee with a mandate  Material datasheets
to prepare guidelines that shall be  Material Physical and
ready before … [date of application Characterization
of this Regulation]. The mandate for testing
the committee shall encompass at  CoC / CoA from the
least a benefit-risk assessment of supplier of the material
the presence of phthalates which  Labeling
belong to either of the groups of  Device & Package
substances referred to in points (a) Labels
and (b) of Section 10.4.1. The
benefit-risk assessment shall take
into account the intended purpose
and context of the use of the device,
as well as any available alternative
substances and alternative
materials, designs or medical
treatments. When deemed
appropriate on the basis of the
justification in
latest scientific evidence, but at
least every five years, the guidelines
shall be updated.
10.4.4 Guidelines on other CMR and
endocrine-disrupting substances
10.4.4 Subsequently, the Commission shall
mandate the relevant scientific
committee to prepare guidelines as
referred to in Section 10.4.3. also for
other substances referred to in
points (a) and (b) of Section 10.4.1.,
where appropriate.
10.4.5 Labelling
10.4.5 Where devices, parts thereof or  Device Labels
materials used therein as referred to  Packaging Labels
in Section 10.4.1. contain substances  Instructions for Use
referred to in points (a) or (b) of
Section 10.4.1. in a concentration
above 0,1 % weight by weight
(w/w), the presence of those
substances shall be labelled on the
device itself and/or on the
packaging for each unit or, where
appropriate, on the sales packaging,
with the list of such substances. If
the intended use of such devices
justification in
includes treatment of children or
treatment of pregnant or
breastfeeding women or treatment
of other patient groups considered
particularly vulnerable to such
substances and/or materials,
information on residual risks for
those patient groups and, if
applicable, on appropriate
precautionary measures shall be
given in the instructions for use.
10.5 Devices shall be designed and  Hazard Analysis/Use
manufactured in such a way as to FMEA/System Risk
reduce as far as possible the risks Assessment
posed by the unintentional ingress  Design Verification
of substances into the device taking testing
into account the device and the
nature of the environment in which
it is intended to be used.
10.6 Devices shall be designed and  Hazard Analysis/Use
manufactured in such a way as to FMEA/System Risk
reduce as far as possible the risks Assessment
linked to the size and the properties  Design Verification
of particles which are or can be testing
released into the patient's or user's
body, unless they come into contact
justification in
with intact skin only. Special
attention shall be given to
nanomaterials.
11. Infection and microbial
contamination
11.1 Devices and their manufacturing
processes shall be designed in such
a way as to eliminate or to reduce as
far as possible the risk of infection to
patients, users and, where
applicable, other persons. The
design shall:
a. reduce as far as possible and  User Training, Usability
appropriate the risks from Studies,
unintended cuts and pricks, such  Hazard
as needle stick injuries Analysis/System Risk
Assessment
 Design FMEA
 Process FMEA
 Software FMEA
 Use FMEA
 Sterilization Validation
b. allow easy and safe handling,  User Training, Usability
Studies,
 Hazard
Analysis/System Risk
justification in
Assessment
 Use FMEA
c. reduce as far as possible any  Design Verification

microbial leakage from the Testing
device and/or microbial  Sterilization Validation
exposure during use, and  Hazard
Assessment
 Use FMEA
If N/A - The [Product Name]

does not include materials that
could leak from the device.
d. prevent microbial contamination  Design Verification
of the device or its content such Testing
as specimens or fluids.  Sterilization Validation
 Hazard
Assessment
 Use FMEA
 Packaging Validation
Report(s)
11.2 Where necessary devices shall be For reusable: Design
designed to facilitate their safe Verification Testing (Cleaning
cleaning, disinfection, and/or re- Validation, Re-sterilization
justification in
sterilization. Validation)
 Labeling
If N/A, [Product Name] is
designed to be single use and is
not intended to be cleaned,
disinfected, or re-sterilized.
11.3 Devices labelled as having a specific  Packaging
microbial state shall be designed, requirements &
manufactured and packaged to specifications
ensure that they remain in that state  Sterilization Validation
when placed on the market and  Shelf Life Studies
remain so under the transport and  Process Validation
storage conditions specified by the
manufacturer.
11.4 Devices delivered in a sterile state  Packaging
shall be designed, manufactured requirements &
and packaged in accordance with specifications
appropriate procedures, to ensure  Sterilization Validation
that they are sterile when placed on  Shelf Life Studies
the market and that, unless the  Process Validation
packaging which is intended to  Packaging Validation
maintain their sterile condition is including Sterile Barrier
damaged, they remain sterile, under Testing
the transport and storage conditions  Transportation Testing
specified by the manufacturer, until  Storage Testing
that packaging is opened at the  Sterilization Validation
justification in
point of use. It shall be ensured that  Shelf Life Studies
the integrity of that packaging is
clearly evident to the final user.
11.5 Devices labelled as sterile shall be  Packaging
processed, manufactured, packaged requirements &
and, sterilized by means of specifications
appropriate, validated methods.  Sterilization Validation
 Process Validation
11.6 Devices intended to be sterilized  Packaging
shall be manufactured and packaged requirements &
in appropriate and controlled specifications
conditions and facilities.  Sterilization Validation
 Process Validation
11.7 Packaging systems for non-sterile  Packaging
devices shall maintain the integrity requirements &
and cleanliness of the product and, specifications
where the devices are to be  Process Validation
sterilized prior to use, minimize the  Device Labels
risk of microbial contamination; the  Packaging Labels
packaging system shall be suitable
taking account of the method of
sterilization indicated by the
manufacturer.
11.8 The labelling of the device shall  Device Labels
distinguish between identical or  Packaging Labels
similar devices placed on the market
justification in
in both a sterile and a non-sterile
condition additional to the symbol
used to indicate that devices are
sterile.
12. Devices incorporating a substance
considered to be a medicinal
product and devices that are
composed of substances or
combination of substances that are
absorbed by or locally dispersed in
the human body
12.1 In the case of devices referred to in  Common Technical
the first subparagraph of Article Documentation (CTD)
1(8), the quality, safety and
usefulness of the substance which, if If N/A - The [Product Name]
used separately, would be does not include or administer
considered to be a medicinal medicinal substances. There is
product within the meaning of point no part of the design or
(2) of Article 1 of Directive configuration of the device that
2001/83/EC, shall be verified by would require compliance to
analogy with the methods specified 2001/83/EC.
in Annex I to Directive 2001/83/EC,
as required by the applicable
conformity assessment procedure
under this Regulation.
2. Devices that are composed of  Common Technical
justification in
1 substances or of combinations of Documentation (CTD)
substances that are intended to be
introduced into the human body, If N/A -The [Product Name] is
and that are absorbed by or locally not composed of substances
dispersed in the human body shall that are intended to be
comply, where applicable and in a introduced into the body, and
manner limited to the aspects not that are absorbed by or locally
covered by this Regulation, with the dispersed in the human body.
relevant requirements laid down in There is no part of the design
Annex I to Directive 2001/83/EC for or configuration of the device
the evaluation of absorption, that would require compliance
distribution, metabolism, excretion, to 2001/83/EC.
local tolerance, toxicity, interaction
with other devices, medicinal
products or other substances and
potential for adverse reactions, as
required by the applicable
conformity assessment procedure
under this Regulation.
13. Devices incorporating materials of
biological origin
13.1 For devices manufactured utilizing
derivatives of tissues or cells of
human origin which are non-viable
or are rendered non-viable covered
by this Regulation in accordance
justification in
with point (g) of Article 1(6), the
following shall apply:
a. donation, procurement and  Hazard Analysis /
testing of the tissues and cells System Risk Assessment
shall be done in accordance with  Use FMEA
Directive 2004/23/EC;  Design Verification
testing
 Biocompatibility Testing
 Pre-clinical testing
If N/A - There are no materials

of human origin used in the
[Product Name].
b. processing, preservation and any  Hazard Analysis /
other handling of those tissues System Risk Assessment
and cells or their derivatives  Hazard Analysis /
shall be carried out so as to System Risk Assessment
provide safety for patients, users  Use FMEA
and, where applicable, other  Design Verification
persons. In particular, safety testing
with regard to viruses and other  Sterilization testing
transmissible agents shall be  Biocompatibility Testing
addressed by appropriate  Pre-clinical testing
methods of sourcing and by
implementation of validated If N/A - There are no materials
methods of elimination or of human origin used in the
justification in
inactivation in the course of the [Product Name].
manufacturing process;  Use FMEA
 Design Verification
testing
 Sterilization testing
 Biocompatibility Testing
 Pre-clinical testing
c. the traceability system for those  Hazard Analysis /
devices shall be complementary System Risk Assessment
and compatible with the  Use FMEA
traceability and data protection  Design Verification
requirements laid down in testing
Directive 2004/23/EC and in
Directive 2002/98/EC. If N/A - There are no materials
of human origin used in the
[Product Name].
13.2 For devices manufactured utilizing
tissues or cells of animal origin, or
their derivatives, which are non-
viable or rendered non-viable the
following shall apply:
a. where feasible taking into  Hazard Analysis /
account the animal species, System Risk
tissues and cells of animal origin, Assessment / Report
or their derivatives, shall  Use FMEA
originate from animals that have  Design Verification
justification in
been subjected to veterinary testing
controls that are adapted to the  Sterilization testing
intended use of the tissues.  Biocompatibility Testing
Information on the geographical  Pre-clinical testing
origin of the animals shall be  DHF/DMR
retained by manufacturers;
If N/A - There are no
components of animal origin in
the [Product Name]
device. Any chemicals, such as
mold release agents
considered as tallow
derivatives have been
processed under conditions at
least as rigorous as those
specified in ISO 22442-1, Annex
C, Section C.5 are considered
exempt from Commission
Regulation 722/2012 of 8
August 2012 (Article 1 Section
4(a)). These are considered
acceptable for TSE risk due to
their processing conditions and
not their sourcing, irrespective
of the geographical origin and
the nature of the tissues from
justification in
which tallow derivatives are
derived.
b. sourcing, processing,  Hazard Analysis /
preservation, testing and System Risk Assessment
handling of tissues, cells and  Use FMEA
substances of animal origin, or  Design Verification
their derivatives, shall be carried testing
out so as to provide safety for  Sterilization testing
patients, users and, where  Biocompatibility Testing
applicable, other persons. In  Pre-clinical testing
particular safety with regard to
viruses and other transmissible If N/A - There are no
agents shall be addressed by components of animal origin in
implementation of validated the [Product Name] device.
methods of elimination or viral Any chemicals, such as mold
inactivation in the course of the release agents considered as
manufacturing process, except tallow derivatives have been
when the use of such methods processed under conditions at
would lead to unacceptable least as rigorous as those
degradation compromising the specified in ISO 22442-1, Annex
clinical benefit of the device; C, Section C.5 are considered
justification in
derived.
c. in the case of devices  Hazard Analysis /
manufactured utilizing tissues or System Risk Assessment
cells of animal origin, or their  Use FMEA
derivatives, as referred to in  Design Verification
Regulation (EU) No 722/2012 testing
the particular requirements laid  Sterilization testing
down in that Regulation shall  Biocompatibility Testing
apply.  Pre-clinical testing
If N/A - There are no

components of animal origin in
the [Product Name] device.
Any chemicals, such as mold
release agents considered as
tallow derivatives have been
processed under conditions at
least as rigorous as those
specified in ISO 22442-1, Annex
C, Section C.5 are considered
justification in
derived.
13.3 For devices manufactured utilizing  Hazard Analysis /
non-viable biological substances System Risk
other than those referred to in Assessment
Sections 13.1 and 13.2, the  Use FMEA
processing, preservation, testing and  Design Verification
handling of those substances shall testing
be carried out so as to provide  Sterilization testing
safety for patients, users and, where  Biocompatibility
applicable, other persons, including Testing
in the waste disposal chain. In  Pre-clinical testing
particular, safety with regard to
viruses and other transmissible If N/A - The [Product Name] is
agents shall be addressed by not manufactured using
appropriate methods of sourcing biological substances other
and by implementation of validated than those referred to in
methods of elimination or Sections 13.1 and 13.2.
justification in
inactivation in the course of the
manufacturing process.
14. Construction of devices and
interaction with their environment
14.1 If the device is intended for use in  Hazard Analysis /
combination with other devices or System Risk
equipment the whole combination, Assessment / Report
including the connection system  Use FMEA
shall be safe and shall not impair the  System Verification
specified performance of the testing
devices. Any restrictions on use  Device Labels
applying to such combinations shall  Packaging Labels
be indicated on the label and/or in
the instructions for use. Connections If N/A - The [Product Name] is
which the user has to handle, such not intended to be used in
as fluid, gas transfer, electrical or combination with other devices
mechanical coupling, shall be that likewise transmit signals
designed and constructed in such a and information Reports
way as to minimize all possible risks, testing interactions or interface
such as misconnection. and connections.
14.2 Devices shall be designed and
remove or reduce as far as possible:
a. the risk of injury, in connection  Hazard Analysis /
with their physical features, System Risk Assessment
including the volume/pressure  Use FMEA
justification in
ratio, dimensional and where  Design Verification
appropriate ergonomic features testing

does not have physical features
that pose risk of injury
b. risks connected with reasonably  Hazard Analysis /
foreseeable external influences System Risk
or environmental conditions, Assessment / Report
such as magnetic fields, external  Use FMEA
electrical and electromagnetic  Design Verification
effects, electrostatic discharge, testing
radiation associated with  EMI/EMC testing
diagnostic or therapeutic  EAS/ESD testing
procedures, pressure, humidity,
temperature, variations in If N/A - The [Product Name]
pressure and acceleration or does not contain materials or
radio signal interferences; components that could be
reasonably foreseeably
impacted by external
influences.
c. the risks associated with the use  Hazard Analysis /
of the device when it comes into System Risk
contact with materials, liquids, Assessment / Report
and substances, including gases,  Use FMEA
to which it is exposed during  Design Verification
justification in
normal conditions of use; testing
d. the risks associated with the  Hazard Analysis /

possible negative interaction System Risk Assessment
between software and the IT  Use FMEA
environment within which it  Design Verification
operates and interacts; testing

does not contain software or
require an IT environment for
operation of the device.
e. the risks of accidental ingress of  Hazard Analysis /
substances into the device; System Risk Assessment
 Use FMEA
testing

does not interact with other
devices during use.
f. the risks of reciprocal  Hazard Analysis /
interference with other devices System Risk Assessment
normally used in the  Use FMEA
investigations or for the  Design Verification
treatment given; and testing
justification in

does not interact with other
devices during use.
g. risks arising where maintenance  Hazard Analysis /
or calibration are not possible System Risk Assessment
(as with implants), from ageing  Use FMEA
of materials used or loss of  Design Verification
accuracy of any measuring or testing
control mechanism.
If N/A - The [Product Name] is
not a diagnostic device and
does not have a measuring
function.
14.3 Devices shall be designed and  Hazard Analysis
manufactured in such a way as to  Design Verification
minimize the risks of fire or testing
explosion during normal use and in
single fault condition. Particular If N/A - There is no risk of fire
attention shall be paid to devices the or explosion associated with
intended use of which includes the [Product Name].
exposure to or use in association
with flammable or explosive
substances or substances which
could cause combustion.
14.4 Devices shall be designed and  Product Manuals,
justification in
manufactured in such a way that Calibration &
adjustment, calibration, and maintenance procedure
maintenance can be done safely and  System Requirements
effectively.  Verification / Validation
Testing

does not require adjustment,
calibration or maintenance.
14.5 Devices that are intended to be  Usability, Human
operated together with other Factors
devices or products shall be  System Verification
designed and manufactured in such testing
a way that the interoperability and
compatibility are reliable and safe.
14.6 Any measurement, monitoring or  Usability, Human
display scale shall be designed and Factors
manufactured in line with
ergonomic principles, taking account If N/A - The [Product Name] is
of the intended purpose, users and not a diagnostic device and
the environmental conditions in does not have a measuring
which the devices are intended to function.
be used.
14.7 Devices shall be designed and  Instructions for Use
facilitate their safe disposal and the
justification in
safe disposal of related waste
substances by the user, patient or
other person. To that end,
manufacturers shall identify and test
procedures and measures as a result
of which their devices can be safely
disposed after use. Such procedures
shall be described in the instructions
for use.
15. Devices with a diagnostic or
measuring function
15.1 Diagnostic devices and devices with  Design Verification
a measuring function, shall be testing
designed and manufactured in such
a way as to provide sufficient
accuracy, precision and stability for
their intended purpose, based on
appropriate scientific and technical
methods. The limits of accuracy shall
be indicated by the manufacturer.
15.2 The measurements made by devices  Design Verification
with a measuring function shall be testing
expressed in legal units conforming
to the provisions of Council Directive
80/181/EEC1.
justification in
16. Protection against radiation
16.1 General
a. Devices shall be designed,  Hazard Analysis /
manufactured and packaged in System Risk
such a way that exposure of Assessment
patients, users and other  Use FMEA
persons to radiation is reduced  Design Verification
as far as possible, and in a testing
manner that is compatible with  EMC/EMI testing
the intended purpose, whilst not
restricting the application of If N/A - The [Product Name] is
appropriate specified levels for not a diagnostic device and
therapeutic and diagnostic does not have a measuring
purposes. function.
b. The operating instructions for  Hazard Analysis /
devices emitting hazardous or System Risk
potentially hazardous radiation Assessment
shall contain detailed  Use FMEA
information as to the nature of  Design Verification
the emitted radiation, the means testing
of protecting the patient and the  EMC/EMI testing
user, and on ways of avoiding
misuse and of reducing the risks If N/A - The [Product Name] is
inherent to installation as far as not a diagnostic device and
possible and appropriate. does not have a measuring
justification in
Information regarding the function.
acceptance and performance
testing, the acceptance criteria,
and the maintenance procedure
shall also be specified.
16.2 Intended radiation
16.2 a. Where devices are designed to  Hazard Analysis /
emit hazardous, or potentially System Risk Assessment
hazardous, levels of ionizing  Use FMEA
and/or non-ionizing radiation  Design Verification
necessary for a specific medical testing
purpose the benefit of which is  EMC/EMI testing
considered to outweigh the risks
inherent to the emission, it shall If N/A - The [Product Name]
be possible for the user to does not emit radiation.
control the emissions. Such
devices shall be designed and
manufactured to ensure
reproducibility of relevant
variable parameters within an
acceptable tolerance.
b. Where devices are intended to  Hazard Analysis /
emit hazardous, or potentially System Risk Assessment
hazardous, ionizing and/or non-  Use FMEA
ionizing radiation, they shall be  Design Verification
fitted, where possible, with testing
justification in
visual displays and/or audible  EMC/EMI testing
warnings of such emissions.
does not emit radiation.
16.3 Devices shall be designed and  Hazard Analysis /
manufactured in such a way that System Risk
exposure of patients, users and Assessment
other persons to the emission of  Use FMEA
unintended, stray or scattered  Design Verification
radiation is reduced as far as testing
possible. Where possible and  EMC/EMI testing
appropriate, methods shall be
selected which reduce the exposure If N/A - The [Product Name]
to radiation of patients, users and does not emit radiation.
other persons who may be affected.
16.4 Ionizing radiation
16.4 a. Devices intended to emit  Hazard Analysis /
ionizing radiation shall be System Risk Assessment
designed and manufactured  Use FMEA
taking into account the  Design Verification
requirements of the Directive testing
2013/59/Euratom laying down
basic safety standards for If N/A - The [Product Name]
protection against the dangers does not emit radiation
arising from exposure to ionizing
justification in
radiation.
b. Devices intended to emit  Hazard Analysis /
ionizing radiation shall be System Risk Assessment
designed and manufactured in  Use FMEA
such a way as to ensure that,  Design Verification
where possible, taking into testing
account the intended use, the
quantity, geometry and quality If N/A - The [Product Name]
of the radiation emitted can be does not emit radiation.
varied and controlled, and, if
possible, monitored during
treatment.
c. Devices emitting ionizing  Hazard Analysis /
radiation intended for diagnostic System Risk Assessment
radiology shall be designed and  Use FMEA
manufactured in such a way as  Design Verification
to achieve an image and/or testing
output quality that are
appropriate to the intended If N/A - The [Product Name]
medical purpose whilst does not emit radiation.
minimizing radiation exposure of
the patient and user.
d. Devices that emit ionizing  Hazard Analysis /
radiation and are intended for System Risk Assessment
therapeutic radiology shall be  Use FMEA
designed and manufactured in  Design Verification
justification in
such a way as to enable reliable testing
monitoring and control of the
delivered dose, the beam type, If N/A - The [Product Name]
energy and, where appropriate, does not emit radiation.
the quality of radiation.
17. Electronic programmable systems –
devices that incorporate electronic
programmable systems and
software that are devices in
themselves
17.1 Devices that incorporate electronic  Hazard Analysis /
programmable systems, including System Risk
software, or software that are Assessment
devices in themselves, shall be  Use FMEA
designed to ensure repeatability,  Software FMEA
reliability and performance in line  Software Des Hazard
with their intended use. In the event Analysis / System Risk
of a single fault condition, Assessment
appropriate means shall be adopted  Use FMEA
to eliminate or reduce as far as  Software FMEA
possible consequent risks or  Software Design and
impairment of performance. V&V testing

does not incorporate software.
17.2 For devices that incorporate  Hazard Analysis /
justification in
software or for software that are System Risk
devices in themselves, the software Assessment
shall be developed and  Use FMEA
manufactured in accordance with  Software FMEA
the state of the art taking into  Software Design and
account the principles of V&V testing
development life cycle, risk
management, including information If N/A - The [Product Name]
security, verification and validation. does not incorporate software.
17.3 Software referred to in this Section  Software Design and
that is intended to be used in V&V testing
combination with mobile computing
platforms shall be designed and If N/A - The [Product Name]
manufactured taking into account does not incorporate software.
the specific features of the mobile
platform (e.g. size and contrast ratio
of the screen) and the external
factors related to their use (varying
environment as regards level of light
or noise).
17.4 Manufacturers shall set out  Hazard Analysis /
minimum requirements concerning System Risk
hardware, IT networks Assessment
characteristics and IT security  Use FMEA
measures, including protection  Software FMEA
against unauthorized access,  Software Design and
justification in
necessary to run the software as V&V testing
intended.
does not incorporate software.
18. Active devices and devices
connected to them
18.1 For non-implantable active devices,  Hazard Analysis /
in the event of a single fault System Risk
condition, appropriate means shall Assessment
be adopted to eliminate or reduce  Use FMEA
as far as possible consequent risks.  Design Verification
testing

not an active device and does
not connect to active devices.
18.2 Devices where the safety of the  Hazard Analysis /
patient depends on an internal System Risk
power supply shall be equipped with Assessment
a means of determining the state of  Use FMEA
the power supply and an  Design Verification
appropriate warning or indication testing
for when the capacity of the power
supply becomes critical. If necessary, If N/A - The [Product Name] is
such warning or indication shall be not an active device and does
given prior to the power supply not connect to active devices.
justification in
becoming critical.
18.3 Devices where the safety of the  Hazard Analysis /
patient depends on an external System Risk
power supply shall include an alarm Assessment
system to signal any power failure.  Use FMEA
testing

18.4 Devices intended to monitor one or  Hazard Analysis /
more clinical parameters of a System Risk
patient shall be equipped with Assessment
appropriate alarm systems to alert  Use FMEA
the user of situations which could  Design Verification
lead to death or severe testing
deterioration of the patient's state  EMI/EMC testing
of health.
manufactured in such a way as to System Risk
reduce as far as possible the risks of Assessment
creating electromagnetic  Use FMEA
justification in
interference which could impair the  Design Verification
operation of the device in question testing
or other devices or equipment in the  EMI/EMC testing
intended environment.
provide a level of intrinsic immunity Assessment
to electromagnetic interference  Use FMEA
such that is adequate to enable  Design Verification
them to operate as intended. testing
 EMI/EMC testing

avoid, as far as possible, the risk of Assessment
accidental electric shocks to the  Use FMEA
patient, user or any other person,  Design Verification
both during normal use of the testing
device and in the event of a single
fault condition in the device, If N/A - The [Product Name] is
justification in
provided the device is installed and not an active device and does
maintained as indicated by the not connect to active devices.
manufacturer.
18. Devices shall be designed and  Hazard Analysis /
protect, as far as possible, against Assessment
unauthorized access that could  Use FMEA
hamper the device from functioning  Design Verification
as intended. testing

19. Particular requirements for active
implantable devices
19.1 Active implantable devices shall be  Hazard Analysis /
designed and manufactured in such System Risk
a way as to remove or minimize as Assessment
far as possible  Use FMEA
testing

not an active implantable
device.
a. risks connected with the use of  Hazard Analysis /
justification in
energy sources with particular System Risk Assessment
reference, where electricity is  Use FMEA
used, to insulation, leakage  Design Verification
currents and overheating of the testing
devices
device.
b. risks connected with medical  Hazard Analysis
treatment, in particular those  Electrical Safety testing
resulting from the use of  Design Verification
defibrillators or high-frequency testing
surgical equipment,
device.
c. risks which may arise where  Hazard Analysis /
maintenance and calibration are System Risk Assessment
impossible, including  Use FMEA
- excessive increase of leakage  Electrical Safety testing
currents,  Design Verification
- ageing of the materials used testing
- excess heat generated by the
device If N/A - The [Product Name] is
- decreased accuracy of any not an active implantable
measuring or control mechanism device.
justification in
19.2 Active implantable devices shall be  Design Verification
designed and manufactured in such Testing Battery Life
a way as to ensure Cycle Process & PSU
- if applicable, the compatibility of Design and Testing
the devices with the substances they
are intended to administer If N/A - The [Product Name] is
- the reliability of the source of not an active implantable
energy device.
19.3 Active implantable devices and, if  Product & Component
appropriate, their component parts Traceability
shall be identifiable to allow any  Laser marking of
necessary measure to be taken barcode
following the discovery of a
potential risk in connection with the If N/A - The [Product Name] is
devices or their component parts not an active implantable
device.
19.4 Active implantable devices shall  Product & Component
bear a code by which they and their Traceability
manufacturer can be unequivocally  Laser marking of
identified (particularly with regard barcode
to the type of device and its year of
manufacture); it shall be possible to If N/A - The [Product Name] is
read this code, if necessary, without not an active implantable
the need for a surgical operation. device.
20. Protection against mechanical and
thermal risks
justification in
protect patients and users against Assessment
mechanical risks connected with, for  Use FMEA
example, resistance to movement,  Design Verification
instability and moving parts testing

reduce to the lowest possible level Assessment
the risks arising from vibration  Use FMEA
generated by the devices, taking  Design Verification
account of technical progress and of testing
the means available for limiting
vibrations, particularly at source, If N/A - There are no risks of
unless the vibrations are part of the generating vibration during use
specified performance of the [Product Name].
reduce to the lowest possible level Assessment
the risks arising from the noise  Use FMEA
emitted, taking account of technical  Design Verification
progress and of the means available testing
to reduce noise, particularly at If N/A - There is no noise
source, unless the noise emitted is generated or emitted during
part of the specified performance. use of the [Product Name].
justification in
20.4 Terminals and connectors to the  Hazard Analysis /
electricity, gas or hydraulic and System Risk
pneumatic energy supplies which Assessment
the user or other person has to  Use FMEA
handle, shall be designed and  Design Verification
constructed in such a way as to testing
minimize all possible risks
does not require use of
electricity, gas, or hydraulic or
pneumatic energy supplies.
20.5 Errors likely to be made when fitting  Hazard Analysis /
or refitting certain parts which could System Risk
be a source of risk shall be made Assessment
impossible by the design and  Use FMEA
construction of such parts or, failing  Design Verification
this, by information given on the testing
parts themselves and/or their
housings.
The same information shall be given
on moving parts and/or their
housings where the direction of
movement needs to be known in
order to avoid a risk.
20.6 Accessible parts of devices  Hazard Analysis /
(excluding the parts or areas System Risk
justification in
intended to supply heat or reach Assessment
given temperatures) and their  Use FMEA
surroundings shall not attain  Design Verification
potentially dangerous temperatures testing
under normal conditions of use.
If N/A, The [Product Name]
does not have a thermal
function.
21. Protection against the risks posed
to the patient or user by devices
supplying energy or substances
21.1 Devices for supplying the patient  Hazard Analysis /
with energy or substances shall be System Risk
designed and constructed in such a Assessment
way that the amount to be  Use FMEA
delivered can be set and maintained  Design Verification
accurately enough to ensure the testing
safety of the patient and of the user.
If N/A, The [Product Name]
does not supply energy or
substances.
21.2 Devices shall be fitted with the  Hazard Analysis /
means of preventing and/or System Risk
indicating any inadequacies in the Assessment
amount of energy delivered or  Use FMEA
substances delivered which could  Design Verification
justification in
pose a danger. Devices shall testing
incorporate suitable means to
prevent, as far as possible, the If N/A, The [Product Name]
accidental release of dangerous does not supply energy or
levels of energy or substances from substances.
an energy and/or substance source.
21.3 The function of the controls and  Understandability of
indicators shall be clearly specified Visual Indicators
on the devices. Where a device  Usability, Human
bears instructions required for its Factors Testing
operation or indicates operating or If N/A - The [Product Name]
adjustment parameters by means of does not supply energy or
a visual system, such information substances.
shall be understandable to the user
and, as appropriate, the patient.
22. Protection against the risks posed
by medical devices intended by the
manufacturer for use by lay persons
22.1 Devices for use by lay persons shall  Hazard
be designed and manufactured in Analysis/System Risk
such a way that they perform Assessment
appropriately for their intended  Use FMEA
purpose taking into account the  Usability, Human
skills and the means available to lay Factors Testing
persons and the influence resulting
from variation that can be If N/A - The [Product Name] is
justification in
reasonably anticipated in the lay not intended to be used by lay
person's technique and persons.
environment. The information and
instructions provided by the
manufacturer shall be easy for the
lay person to understand and apply.
Devices for use by lay persons shall
be designed and manufactured in
such a way as to:
- ensure that the device can be used
safely and accurately by the
intended user at all stages of the
procedure, if necessary after
appropriate training and/or
information,
- reduce, as far as possible and
appropriate, the risk from
unintended cuts and pricks such as
needle stick injuries, and
- reduce as far as possible the risk of
error by the intended user in the
handling of the device and, if
applicable, in the interpretation of
the results.
Devices for use by lay persons shall,
where appropriate, include a
justification in
procedure by which the lay person:
- can verify that, at the time of use,
the device will perform as intended
by the manufacturer, and
- if applicable, is warned if the
device has failed to provide a valid
result.
Chapter – III Requirements regarding the information supplied with the device
23. Label and instructions for use
23.1 General requirements regarding the

information supplied by the
manufacturer
Each device shall be accompanied by
the information needed to identify
the device and its manufacturer, and
by any safety and performance
information relevant to the user, or
any other person, as appropriate.
Such information may appear on the
device itself, on the packaging or in
the instructions for use, and shall, if
the manufacturer has a website, be
made available and kept up to date
on the website, taking into account
the following:
justification in
a. The medium, format, content,  Usability Studies
legibility, and location of the  Device labels
label and instructions for use  Package Label
shall be appropriate to the  Instructions for Use
particular device, its intended
purpose and the technical
knowledge, experience,
education or training of the
intended user(s). In particular,
instructions for use shall be
written in terms readily
understood by the intended user
and, where appropriate,
supplemented with drawings
and diagrams.
b. The information required on the  Labeling (Device Labels,
label shall be provided on the Packaging Labels, IFU)
device itself. If this is not
practicable or appropriate, some
or all of the information may
appear on the packaging for
each unit, and/or on the
packaging of multiple devices.
c. Labels shall be provided in a  Labeling (Device Labels,
human-readable format and Packaging Labels, IFU)
may be supplemented by
justification in
machine-readable information,
such as radio-frequency
identification ('RFID') or bar
codes.
d. Instructions for use shall be  Instructions for Use
provided together with devices.
By way of exception, instructions
for use shall not be required for
class I and class IIa devices if
such devices can be used safely
without any such instructions
and unless otherwise provided
for elsewhere in this Section.
e. Where multiple devices are  Instructions for Use
supplied to a single user and/or
location, a single copy of the
instructions for use may be
provided if so agreed by the
purchaser who in any case may
request further copies to be
provided free of charge.
f. Instructions for use may be  eIFU insert
provided to the user in non-
paper format (e.g. electronic) to
the extent, and only under the
conditions, set out in Regulation
justification in
(EU) No 207/2012 or in any
subsequent implementing rules
adopted pursuant to this
Regulation.
g. Residual risks which are required  Instructions for Use
to be communicated to the user
and/or other person shall be
included as limitations, contra-
indications, precautions or
warnings in the information
supplied by the manufacturer.
h. Where appropriate, the  Labeling (Device Labels,
information supplied by the Packaging Labels, IFU)
manufacturer shall take the
form of internationally
recognized symbols. Any symbol
or identification color used shall
conform to the harmonized
standards or CS. In areas for
which no harmonized standards
or CS exist, the symbols and
colors shall be described in the
documentation supplied with
the device.
23.2 Information on the label: The label
shall bear all of the following
justification in
particulars:
a. the name or trade name of the  Labeling (Device Labels,
device; Packaging Labels, IFU)
b. the details strictly necessary for  Labeling (Device Labels,
a user to identify the device, the Packaging Labels, IFU)
contents of the packaging and,
where it is not obvious for the
user, the intended purpose of
the device;
c. the name, registered trade  Labeling (Device Labels,
name or registered trade mark Packaging Labels, IFU)
of the manufacturer and the
address of its registered place of
business;
d. if the manufacturer has its  Labeling (Device Labels,
registered place of business Packaging Labels, IFU)
outside the Union, the name of
the authorized representative
and address of the registered
place of business of the
authorized representative
e. where applicable, an indication  Labeling (Device Labels,
that the device contains or Packaging Labels, IFU)
incorporates:
– a medicinal substance,
justification in
including a human blood or
plasma derivative, or
– tissues or cells, or their
derivatives, of human origin, or
– tissues or cells of animal origin,
or their derivatives, as referred
to in Regulation (EU) No
722/2012;
f. where applicable, information  Labeling (Device Labels,
labelled in accordance with Packaging Labels, IFU)
Section 10.4.5.;
g. the lot number or the serial  Labeling (Device Labels,
number of the device preceded Packaging Labels, IFU)
by the words LOT NUMBER or
SERIAL NUMBER or an
equivalent symbol, as
appropriate;
h. the UDI carrier referred to in  Labeling (Device Labels,
Article 27(4) and Part C of Annex Packaging Labels, IFU)
VII;
i. an unambiguous indication of t  Labeling (Device Labels,
the time limit for using or Packaging Labels, IFU)
implanting the device safely,
expressed at least in terms of
year and month, where this is
justification in
relevant;
j. where there is no indication of  Labeling (Device Labels,
the date until when it may be Packaging Labels, IFU)
used safely, the date of
manufacture. This date of
manufacture may be included as
part of the lot number or serial
number, provided the date is
clearly identifiable;
k. an indication of any special  Labeling (Device Labels,
storage and/or handling Packaging Labels, IFU)
condition that applies;
l. if the device is supplied sterile,  Labeling (Device Labels,
an indication of its sterile state Packaging Labels, IFU)
and the sterilization method;
m. warnings or precautions to be  Labeling (Device Labels,
taken that need to be brought to Packaging Labels, IFU)
the immediate attention of the
user of the device, and to any
other person. This information
may be kept to a minimum in
which case more detailed
information shall appear in the
instructions for use, taking into
account the intended users;
justification in
n. if the device is intended for  Labeling (Device Labels,
single use, an indication of that Packaging Labels, IFU)
fact. A manufacturer's indication
of single use shall be consistent
across the Union;
o. if the device is a single-use  Device Labels
device that has been  Packaging Labels
reprocessed, an indication of
that fact, the number of If N/A – The [Product Name] is
reprocessing cycles already intended for single use.
performed, and any limitation as
regards the number of
reprocessing cycles;
p. if the device is custom-made,  Device Labels
the words 'custom-made  Packaging Labels
device';
If N/A – The [Product Name] is
not a custom made device.
q. an indication that the device is a  Labeling (Device Labels,
medical device. If the device is Packaging Labels, IFU)
intended for clinical
investigation only, the words
'exclusively for clinical
investigation';
r. in the case of devices that are  Device Labels
justification in
composed of substances or of  Packaging Labels
combinations of substances that
are intended to be introduced If N/A - The [Product Name] is
into the human body via a body not introduced into the body
orifice or applied to the skin and via body orifice or by skin
that are absorbed by or locally contact.
dispersed in the human body,
the overall qualitative
composition of the device and
quantitative information on the
main constituent or constituents
responsible for achieving the
principal intended action;
s. for active implantable devices,  Device Labels
the serial number, and for other  Packaging Labels
implantable devices, the serial
number or the lot number. If N/A - The [Product Name] is
device.
23.3 Information on the packaging which
maintains the sterile condition of a
device ('sterile packaging')
The following particulars shall
appear on the sterile packaging:
a. an indication permitting the  Sterile Pack Labeling
sterile packaging to be Contents
justification in
recognized as such,
b. a declaration that the device is  Sterile Pack Labeling
in a sterile condition, Contents
c. the method of sterilization,  Sterile Pack Labeling
Contents
d. the name and address of the  Sterile Pack Labeling
manufacturer, Contents
e. a description of the device,  Sterile Pack Labeling
Contents
f. if the device is intended for  Sterile Pack Labeling
clinical investigations, the words Contents
'exclusively for clinical
investigations',
g. if the device is custom-made,  Sterile Pack Labeling
the words 'custom-made Contents
device',
h. the month and year of  Sterile Pack Labeling
manufacture, Contents
i. an unambiguous indication of  Sterile Pack Labeling
the time limit for using or Contents
implanting the device safely
expressed at least in terms of
year and month, and
j. an instruction to check the  Sterile Pack Labeling
instructions for use for what to Contents
justification in
do if the sterile packaging is
damaged or unintentionally
opened before use.
23.4 Information in the instructions for
use
The instructions for use shall contain
all of the following particulars:
a. the particulars referred to in  Instructions for Use
points (a), (c), (e), (f), (k), (l), (IFU)
(n) and (r) of Section 23.2;
b. the device's intended purpose  Instructions for Use
with a clear specification of
indications, contra-indications,
the patient target group or
groups, and of the intended
users, as appropriate;
c. where applicable, a specification  Instructions for Use
of the clinical benefits to be
expected.
d. where applicable, links to the  Instructions for Use
summary of safety and clinical
performance referred to in
Article 32;
e. the performance characteristics  Instructions for Use
of the device;
justification in
f. where applicable, information  Instructions for Use
allowing the healthcare
professional to verify if the
device is suitable and select the
corresponding software and
accessories;
g. any residual risks, contra-  Instructions for Use
indications and any undesirable
side-effects, including
information to be conveyed to
the patient in this regard;
h. specifications the user requires  Instructions for Use
to use the device appropriately,
e.g. if the device has a
measuring function, the degree
of accuracy claimed for it;
i. details of any preparatory  Instructions for Use
treatment or handling of the
device before it is ready for use
or during its use, such as
sterilization, final assembly,
calibration, etc., including the
levels of disinfection required to
ensure patient safety and all
available methods for achieving
those levels of disinfection;
justification in
j. any requirements for special  Instructions for Use
facilities, or special training, or
particular qualifications of the
device user and/or other
persons;
k. the information needed to verify  Instructions for Use
whether the device is properly
installed and is ready to perform
safely and as intended by the
manufacturer, together with,
where relevant:
– details of the nature, and
frequency, of preventive and
regular maintenance, and of any
preparatory cleaning or
disinfection,
– identification of any
consumable components and
how to replace them,
– information on any necessary
calibration to ensure that the
device operates properly and
safely during its intended
lifetime, and
– methods for eliminating the
risks encountered by persons
justification in
involved in installing, calibrating
or servicing devices;
l. if the device is supplied sterile,  Instructions for Use
instructions in the event of the
sterile packaging being damaged
or unintentionally opened
before use;
m. if the device is supplied non-  Instructions for Use
sterile with the intention that it
is sterilized before use, the If N/A - The [Product Name] is
appropriate instructions for supplied sterile.
sterilization;
n. if the device is reusable,  Instructions for Use
information on the appropriate
processes for allowing reuse, If N/A - The [Product Name] is
including cleaning, disinfection, intended for single use only.
packaging and, where
appropriate, the validated
method of re-sterilization
appropriate to the Member
State or Member States in which
the device has been placed on
the market. Information shall be
provided to identify when the
device should no longer be
reused, e.g. signs of material
justification in
degradation or the maximum
number of allowable reuses;
o. an indication, if appropriate,  Instructions for Use
that a device can be reused only
if it is reconditioned under the If N/A - The [Product Name] is
responsibility of the intended for single use only.
manufacturer to comply with
the general safety and
performance requirements;
p. if the device bears an indication  Instructions for Use
that it is for single use,
information on known
characteristics and technical
factors known to the
manufacturer that could pose a
risk if the device were to be re-
used. This information shall be
based on a specific section of
the manufacturer's risk
management documentation,
where such characteristics and
technical factors shall be
addressed in detail. If in
accordance with point (d) of
Section 23.1. no instructions for
use are required, this
justification in
information shall be made
available to the user upon
request;
q. for devices intended for use  Instructions for Use
together with other devices
and/or general purpose
equipment:
– information to identify such
devices or equipment, in order
to obtain a safe combination,
and/or
– information on any known
restrictions to combinations of
devices and equipment;
r. if the device emits radiation for  Instructions for Use
medical purposes:
– detailed information as to the If N/A - The [Product Name]
nature, type and where does not emit radiation.
appropriate, the intensity and
distribution of the emitted
radiation,
– the means of protecting the
patient, user, or other person
from unintended radiation
during use of the device;
s. information that allows the user  Instructions for Use
justification in
and/or patient to be informed of  Materials Assessment
any warnings, precautions,
contra-indications, measures to
be taken and limitations of use
regarding the device. That
information shall, where
relevant, allow the user to brief
the patient about any warnings,
precautions, contra-indications,
measures to be taken and
limitations of use regarding the
device. The information shall
cover, where appropriate:
– warnings, precautions and/or
measures to be taken in the
event of malfunction of the
device or changes in its
performance that may affect
safety,
measures to be taken as regards
the exposure to reasonably
foreseeable external influences
or environmental conditions,
such as magnetic fields, external
electrical and electromagnetic
justification in
effects, electrostatic discharge,
radiation associated with
diagnostic or therapeutic
procedures, pressure, humidity,
or temperature,
measures to be taken as regards
the risks of interference posed
by the reasonably foreseeable
presence of the device during
specific diagnostic
investigations, evaluations, or
therapeutic treatment or other
procedures such as
electromagnetic interference
emitted by the device affecting
other equipment,
– if the device is intended to
administer medicinal products,
tissues or cells of human or
animal origin, or their
derivatives, or biological
substances, any limitations or
incompatibility in the choice of
substances to be delivered,
justification in
limitations related to the
medicinal substance or
biological material that is
incorporated into the device as
an integral part of the device;
and
– precautions related to
materials incorporated into the
device that contain or consist of
CMR substances or endocrine-
disrupting substances, or that
could result in sensitization or an
allergic reaction by the patient
or user;
t. in the case of devices that are  Instructions for Use
composed of substances or of
combinations of substances that
are intended to be introduced
into the human body and that
are absorbed by or locally
dispersed in the human body,
warnings and precautions,
where appropriate, related to
the general profile of interaction
of the device and its products of
metabolism with other devices,
justification in
medicinal products and other
substances as well as contra-
indications, undesirable side-
effects and risks relating to
overdose;
u. in the case of implantable  Instructions for Use
devices, the overall qualitative  CER
and quantitative information on
the materials and substances to
which patients can be exposed;
v. warnings or precautions to be  Instructions for Use
taken in order to facilitate the
safe disposal of the device, its
accessories and the
consumables used with it, if any.
This information shall cover,
where appropriate:
– infection or microbial hazards
such as explants, needles or
surgical equipment
contaminated with potentially
infectious substances of human
origin, and
– physical hazards such as from
sharps.
If in accordance with the point
justification in
(d) of Section 23.1 no
instructions for use are required,
this information shall be made
available to the user upon
request;
w. for devices intended for use by  Instructions for Use
lay persons, the circumstances in
which the user should consult a If N/A - The [Product Name] is
healthcare professional; not intended for use by
laypersons.
x. for the devices covered by this  Instructions for Use
Regulation pursuant to Article
1(2), information regarding the If N/A - The [Product Name] is
absence of a clinical benefit and not a device without clinical
the risks related to use of the benefit
device;
y. date of issue of the instructions  Instructions for Use
for use or, if they have been
revised, date of issue and
identifier of the latest revision of
the instructions for use;
z. a notice to the user and/or  Instructions for Use /
patient that any serious incident Patient Manual
that has occurred in relation to
the device should be reported to
justification in
the manufacturer and the
competent authority of the
Member State in which the user
and/or patient is established;
aa. information to be supplied to  Patient Manual
the patient with an implanted
device in accordance with Article
18;
ab. for devices that incorporate  Instructions for Use
electronic programmable
systems, including software, or If N/A - The [Product Name]
software that are devices in does not use or contain
themselves, minimum electronic programmable
requirements concerning systems or software.
hardware, IT networks
characteristics and IT security
measures, including protection
against unauthorized access,
necessary to run the software as
intended.

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1.

Device Model Number(s) Device Name Description

3. Applicable Standards / Documents

List all related standards:

Table 1. Standards, Common Specifications, and Procedures References

Device Specific Standards Title

Clinical Standards Title

Biocompatibility Standards Title

Packaging Standards Title

Sterilization Standards Title

Environmental Control Standards Title

Table 2. Documents References

4. General Safety & Performance (GSPR) Checklist

Column 1 Column 2 Column 3 Column 4 Column 5

1. Patient safety and intended

e. evaluate the impact of  Risk Management File

5. In eliminating or reducing risks  Hazard

6. The characteristics and performance  Risk Management File

7. Devices shall be designed,  Performance

If N/A, There is no risk of fire or

e. where appropriate, the results  Material Physical and

f. the mechanical properties of the  Material Physical and

10.4.1 Design and manufacture of devices

10.4.1 Devices shall be designed and  Aging Test Reports

10.4.3 For the purposes of Section 10.4.,  Hazard Analysis/Use

c. reduce as far as possible any  Design Verification

If N/A - The [Product Name]

If N/A - There are no materials

If N/A - There are no

If N/A - The [Product Name]

d. the risks associated with the  Hazard Analysis /

If N/A - The [Product Name]

If N/A - The [Product Name]

If N/A - The [Product Name]

If N/A - The [Product Name]

If N/A - The [Product Name]

If N/A - The [Product Name] is

If N/A - The [Product Name] is

If N/A - The [Product Name] is

If N/A - The [Product Name] is

If N/A - The [Product Name] is

20.2 Devices shall be designed and  Hazard Analysis /

23.1 General requirements regarding the

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