File No: TCF-CE-003

Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
I General requirements
The devices must be designed and manufactured in such a way that, when used under A EN980 Risk analysis report OK
the conditions and for the purposes intended, they will not compromise the clinical ISO14971 Test Report
condition or the safety of patients, or the safety and health of users or, where applicable,
other persons, provided that any risks which may be associated with their intended use EN 60601-1
constitute acceptable risks when weighed against the benefits to the patient and are
compatible with a high level of protection of health and safety.
1. This shall include:
— reducing, as far as possible, the risk of use error due to the ergonomic features of the
device and the environment in which the device is intended to be used (design for patient
safety), and
— consideration of the technical knowledge, experience, education and training and
where applicable the medical and physical conditions of intended users (design for lay,
professional, disabled or other users).
The solutions adopted by the manufacturer for the design and construction of the devices A ISO14971 Risk analysis report OK
must conform to safety principles, taking account of the generally acknowledged state of
the art.
In selecting the most appropriate solutions, the manufacturer must apply the following
principles in the following order:
2. – eliminate or reduce risks as far as possible (inherently safe design and
construction),
– where appropriate take adequate protection measures including alarms if necessary,
in relation to risks that cannot be eliminated,
– inform users of the residual risks due to any shortcomings of the protection measures
adopted.
The devices must achieve the performances intended by the manufacturer and be de- A EN980 IFU OK
3. signed, manufactured and packaged in such a way that they are suitable for one or more
of the functions referred to in Article 1 (2) (a), as specified by the manufacturer.
The characteristics and performances referred to in Sections 1, 2 and 3 must not be A EN980 IFU OK
adversely affected to such a degree that the clinical conditions and safety of the patients
4. and, where applicable, of other persons are compromised during the lifetime of the
device as indicated by the manufacturer, when the device is subjected to the stresses
which can occur during normal conditions of use.
 File No: TCF-CE-003
Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
The devices must be designed, manufactured and packed in such a way that their A EN980 IFU OK
characteristics and performances during their intended use will not be adversely affected ISO 14971 Labeling
5.
during transport and storage taking account of the instructions and information provided
by the manufacturer.
6. Any undesirable side-effect must constitute an acceptable risk when weighed against the A ISO14971 Risk analysis report OK
performances intended.
a. Demonstration of conformity with the essential requirements must include a clinical
evaluation in accordance with Annex X.
II Requirements regarding design and construction
A ISO10993-1 Test Report OK
7. Chemical, physical and biological properties ISO10993-5
ISO10993-10
7.1. The devices must be designed and manufactured in such a way as to guarantee the
characteristics and performances referred to in Section I on the ‘General requirements’.
Particular attention must be paid to:
— the choice of materials used, particularly as regards toxicity and, where appropriate,
flammability,
— the compatibility between the materials used and biological tissues, cells and body
fluids, taking account of the intended purpose of the device,
— where appropriate, the results of biophysical or modeling research whose validity has
been demonstrated beforehand.
7.2. The devices must be designed, manufactured and packed in such a way as to minimize A ISO10993-1 Test Report OK
the risk posed by contaminants and residues to the persons involved in the transport, ISO10993-5
storage and use of the devices and to the patients, taking account of the intended ISO10993-10
purpose of the product. Particular attention must be paid to the tissues exposed and to
the duration and frequency of exposure.
7.3. The devices must be designed and manufactured in such a way that they can be used A EN980 IFU OK
safely with the materials, substances and gases with which they enter into contact during ISO14971 Risk Analysis Report
their normal use or during routine procedures; if the devices are intended to administer
medicinal products they must be designed and manufactured in such a way as to be
compatible with the medicinal products concerned according to the provisions and
restrictions governing these products and that their performance is maintained in
accordance with the intended use.
 File No: TCF-CE-003
Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be NA
considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable
to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the
substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/ EC.
For the substances referred to in the first paragraph, the notified body shall, having verified the
usefulness of the substance as part of the medical device and taking account of the intended purpose of
the device, seek a scientific opinion from one of the competent authorities designated by the Member
States or the European Medicines Agency (EMEA) acting particularly through its committee in
accordance with Regulation (EC) No 726/2004 (1) on the quality and safety of the substance including
the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its
opinion, the competent authority or the EMEA shall take into account the manufacturing process and the
data related to the usefulness of incorporation of the substance into the device as determined by the
notified body.
Where a device incorporates, as an integral part, a human blood derivative, the notified body shall,
having verified the usefulness of the substance as part of the medical device and taking into account the
intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its
committee, on the quality and safety of the substance including the clinical benefit/risk profile of the
incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall
take into account the manufacturing process and the data related to the usefulness of incorporation of
the substance into the device as determined by the notified body.
Where changes are made to an ancillary substance incorporated in a device, in particular related to its
manufacturing process, the notified body shall be informed of the changes and shall consult the relevant
medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that
the quality and safety of the ancillary substance are maintained. The competent authority shall take into
account the data related to the usefulness of incorporation of the substance into the device as
determined by the notified body, in order to ensure that the changes have no negative impact on the
established benefit/risk profile of the addition of the substance in the medical device.
When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has
obtained information on the ancillary substance, which could have an impact on the established
benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified
body with advice, whether this information has an impact on the established benefit/risk profile of the
addition of the substance in the medical device or not. The notified body shall take the updated scientific
opinion into account in reconsidering its assessment of the conformity assessment procedure.
7.5. The devices must be designed and manufactured in such a way as to reduce to a NA
minimum the risks posed by substances leaking from the device. Special attention shall
be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in
accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the
approximation of laws, regulations and administrative provisions relating to the
classification, packaging and labeling of dangerous substances.

If parts of a device (or a device itself) intended to administer and/or remove medicines,
body liquids or other substances to or from the body, or devices intended for transport
and storage of such body fluids or substances, contain phthalates which are classified as
carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with
Annex I to Directive 67/548/EEC, these devices must be labeled on the device itself
and/or on the packaging for each unit or, where appropriate, on the sales packaging as a
device containing phthalates.

If the intended use of such devices includes treatment of children or treatment of

pregnant or nursing women, the manufacturer must provide a specific justification for the
use of these substances with regard to compliance with the essential requirements, in
particular of this paragraph, within the technical documentation and, within the
instructions for use, information on residual risks for these patient groups and, if
applicable, on appropriate precautionary measures.

7.6. The devices must be designed and manufactured in such a way as to reduce as much as NA
possible, risks posed by the unintentional ingress of substances into the device taking
into account the device and the nature of the environment in which it is intended to be
used.
 File No: TCF-CE-003

Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
A ISO 14971 Risk management OK
8. Infection and microbial contamination report

8.1.
The devices and manufacturing processes must be designed in such as way as to
eliminate or reduce as far as possible the risk of infection to the patient, user and third
parties. The design must allow easy handling and, where necessary, minimize
contamination of the device by the patient or vice versa during use.
8.2. Tissues of animal origin must originate from animals that have been subjected to NA
veterinary controls and surveillance adapted to the intended use of the tissues.
Notified bodies shall retain information on the geographical origin of the animals.
Processing, preservation, testing and handling of tissues, cells and substances of animal
origin must be carried out so as to provide optimal security. In particular safety with
regard to viruses and other transferable agents must be addressed by implementation of
validated methods of elimination or viral inactivation in the course of the manufacturing
process.
8.3. Devices delivered in a sterile state must be designed, manufactured and packed in a NA
non-reusable pack and/or according to appropriate procedures to ensure that they are
sterile when placed on the market and remain sterile, under the storage and transport
conditions laid down, until the protective packaging is damaged or opened.
8.4. Devices delivered in a sterile state must have been manufactured and sterilized by an NA
appropriate, validated method.
8.5. Devices intended to be sterilized must be manufactured in appropriately controlled (e.g. NA
environmental) conditions.
8.6. Packaging systems for non-sterile devices must keep the product without deterioration at NA
the level of cleanliness stipulated and, if the devices are to be sterilized prior to use,
minimize the risk of microbial contamination; the packaging system must be suitable
taking account of the method of sterilization indicated by the manufacturer.
8.7 The packaging and/or label of the device must distinguish between identical or similar NA
products sold in both sterile and non-sterile condition.
 File No: TCF-CE-003

Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
9. NA
Construction and environmental properties
9.1.
If the device is intended for use in combination with other devices or equipment, the whole
combination, including the connection system must be safe and must not impair the
specified performances of the devices. Any restrictions on use must be indicated on the
label or in the instructions for use.
9.2. Devices must be designed and manufactured in such a way as to remove or minimize as far A EN980 IFU OK
as is possible: ISO14971 Risk Analysis
– the risk of injury, in connection with their physical features, including the Report
volume/pressure ration, dimensional and where appropriate ergonomic features,
– risks connected with reasonably foreseeable environmental conditions, such as
magnetic fields, external electrical influences, electrostatic discharge, pressure,
temperature or variations in pressure and acceleration,
– the risks of reciprocal interference with other devices normally used in the investigations
of for the treatment given,
– risks arising when maintenance or calibration are not possible (as with implants), from
ageing of materials used or loss of accuracy of any measuring or control mechanism.
9.3. Devices must be designed and manufactured in such a way as to minimize the risks of fire NA
or explosion during normal use and single fault condition. Particular attention must be paid
to devices whose intended use includes exposure to flammable substances or to
substances which could cause combustion
 File No: TCF-CE-003

Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
10. Devices with a measuring function NA
10.1. Devices with a measuring function must be designed and manufactured in such a way
as to provide sufficient accuracy and stability within appropriate limits of accuracy and
taking account of the intended purpose of the device. The limits of accuracy must be
indicated by the manufacturer.
10.2. The measurement, monitoring and display scale must be designed in line with NA
ergonomic principles, taking account of the intended purpose of the device.
10.3. The measurements made by devices with a measuring function must be expressed in NA
legal units conforming to the provisions of Council Directive 80/181/EEC.
A EN60601-1-2 Risk analysis report OK
11. Protection against radiation :2007 Test Report

11.1.
11.1.1 General
Devices shall be designed and manufactured in such a way that exposure of patients,
users and other persons to radiation shall be reduced as far as possible compatible
with the intended purpose, whilst not restricting the application of appropriate specified
levels for therapeutic and diagnostic purposes.
11.2. Intended radiation A EN60601-1-2 Risk analysis report OK
11.2.1 Where devices are designed to emit hazardous levels of radiation necessary for a :2007 Test Report
specific medical purpose the benefit of which is considered to outweigh the risks
inherent in the emission, it must be possible for the user to control the emissions. Such
devices shall be designed and manufactured to ensure reproducibility and tolerance of
relevant variable parameters.
11.2.2 Where devices are intended to emit potentially hazardous, visible and/or invisible A EN60601-1-2 Risk analysis report OK
radiation, they must be fitted, where practicable, with visual displays and/or audible :2007 Test Report
warnings of such emissions.

File No: TCF-CE-003

Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
11.3. Unintended radiation A EN60601-1- Risk analysis report OK
11.3.1 Devices shall be designed and manufactured in such a way that exposure of patients, 2:2007 Test Report
users and other persons to the emission of unintended, stray or scattered radiation is
reduced as far as possible.
11.4. Instructions A EN60601-1- Risk analysis report OK
The operating instructions for devices emitting radiation must give detailed information 2:2007 Test Report
11.4.1 as to the nature of the emitted radiation, means of protecting the patient and the user
and on ways of avoiding misuse of eliminating the risks inherent in installation.
11.5. Ionizing radiation A EN60601-1- Risk analysis report OK
11.5.1 Devices intended to emit ionizing radiation must be designed and manufactured in 2:2007 Test Report
such a way as to ensure that, where practicable, the quantity, geometry and quality of
radiation emitted can be varied and controlled taking into account the intended use.
11.5.2 Devices emitting ionizing radiation intended for diagnostic radiology shall be designed A EN60601-1- Risk analysis report OK
and manufactured in such a way as to achieve appropriate image and/or output quality 2:2007 Test Report
for the intended medical purpose whilst minimizing radiation exposure of the patient
and user.
11.5.3 Devices emitting ionizing radiation, intended for therapeutic radiology shall be A EN60601-1- Risk analysis report OK
designed and manufactured in such a way as to enable reliable monitoring and control 2:2007 Test Report
of the delivered dose, the beam type and energy and where appropriate the quality of
radiation.
12. Requirements for medical devices connected to or equipped with an energy NA
12.1. source
Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and
performance of these systems according to the intended use. In the event of a single fault condition (in the system)
appropriate means should be adopted to eliminate or reduce as far as possible consequent risks.
12.1a For devices which incorporate software or which are medical software in themselves, the software must be
validated according to the state of the art taking into account the principles of development lifecycle, risk management,
validation and verification.
12.2. Devices where the safety of the patients depends on an internal power supply must be NA
equipped with a means of determining the state of the power supply.
12.3. Devices where the safety of the patients depends on an external power supply must A EN980 Risk analysis report OK
ISO14971
include an alarm system to signal any power failure. Test Report
EN 60601-1
 File No: TCF-CE-003

Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
12.4. Devices intended to monitor one or more clinical parameters of a patient must be NA
equipped with appropriate alarm systems to alert the user of situations which could
lead to death or severe deterioration of the patient's state of health.
12.5. Devices must be designed and manufactured in such a way as to minimize the risks of A EN980 Risk analysis report OK
creating electromagnetic fields, which could impair the operation of other devices or ISO14971 Test Report
equipment in the usual environment.
EN 60601-1

12.6. Protection against electrical risks A EN980 Risk analysis report OK

ISO14971 Test Report
Devices must be designed and manufactured in such a way as to avoid, as far as
possible, the risk of accidental electric shocks during normal use and in single fault EN 60601-1
condition, provided the devices are installed correctly.
12.7. Protection against mechanical and thermal risks A EN980 Risk analysis report OK
ISO14971 Test Report
12.7.1 Devices must be designed and manufactured in such a way as to protect the patient
and user against mechanical risk connected with, for example, resistance, stability and EN 60601-1
moving parts.
12.7.2 Devices must be designed and manufactured in such a way as to reduce to the lowest A EN980 Risk analysis report OK
possible level the risks arising from vibration generated by the devices, taking account ISO14971 Test Report
of technical progress and of the means available for limiting vibrations, particularly at
source, unless the vibrations are part of the specified performance. EN 60601-1

12.7.3 Devices must be designed and manufactured in such a way as to reduce to the lowest A EN980 Risk analysis report OK
possible level the risks arising from the noise emitted, taking account of technical ISO14971 Test Report
progress and of the means available to reduce noise, particularly at source, unless the
noise emitted is part of the specified performance. EN 60601-1

12.7.4 Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy NA
supplies which the user has to handle must be designed and constructed in such a way
as to minimize all possible risks.
 File No: TCF-CE-003

Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
12.7.5 Accessible parts of the devices (excluding the parts or areas intended to supply heat or NA
reach given temperatures) and their surroundings must not attain potentially dangerous
temperatures under normal use.
12.8. Protection against the risks posed to the patient by energy supplies or substances A EN980 Risk analysis report OK
ISO14971 Test Report
12.8.1 Devices for supplying the patient with energy or substances must be designed and con-
structed in such a way that the flow-rate can be set and maintained accurately enough to EN 60601-1
guarantee the safety of the patient and of the user.
12.8.2 Devices must be fitted with the means of preventing and/or indicating any inadequacies A EN980 Risk analysis report OK
in the flow-rate, which could pose a danger. ISO14971 Test Report
Devices must incorporate suitable means to prevent, as far as possible, the accidental
release of dangerous levels of energy from an energy and/or substance source. EN 60601-1

12.9. The function of the controls and indicators must be clearly specified on the devices. A EN980 Risk analysis report OK
Where a device bears instructions required for its operation or indicates operating or ISO14971 Test Report
adjustment parameters by means of a visual system, such information must be
understandable to the user and, as appropriate, the patient. EN 60601-1

13. Information supplied by the manufacturer A EN1041 Instruction of use OK

Each device must be accompanied by the information needed to use it safely and EN980 Label
13.1. properly, taking account of the training and knowledge of the potential users, and to
identify the manufacturer. This information comprises the details on the label and the
data in the instructions for use.
13.2 Where appropriate, this information should take the form of symbols. Any symbol or A EN980 Instruction of use OK
identification colour used must conform to the harmonized standards. In areas for which
no standards exist, the symbols and colours must be described in the documentation
supplied with the device.
 File No: TCF-CE-003
Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
13.3 The label must bear the following particulars: A EN980 Instruction of use OK
(a) the name or trade name and address of the manufacturer. For devices imported into Labeling
the Community, in view of their distribution in the Community, the label, or the outer
packaging, or instructions for use, shall contain in addition the name and address of the
authorized representative where the manufacturer does not have a registered place of
business in the Community;
(b) the details strictly necessary for the user to identify the device and the contents of A OK
EN980 Instruction of use
the packaging;
(c) where appropriate, the word 'STERILE'; NA The device is not sterile.
(d) where appropriate, the batch code, preceded by the work 'LOT', or the serial A OK
EN980 Instruction of use
number;
(e) where appropriate, an indication of the date by which the device should be used, in NA
safety, expressed as the year and the month;
(f) where appropriate, an indication that the device is for single use. A manufacturer's NA The device is not for
indication of single use must be consistent across the Community; A manufacturer's single use.
indication of single use must be consistent across the Community;

(g) if the device is custom-made, the words 'custom-made device'; NA The device is not
custom-made.
(h) if the device is intended for clinical investigations, the words 'exclusively for clinical NA The device is not clinical
investigations'; investigations.
Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
13.3 (i) any special storage and/or handling conditions; NA
(j) any special operating instructions; NA
(k) any warnings and/or precautions to take; A EN980 Instruction of use OK
(l) year of manufacture for active devices other than those covered by (e). This NA
indication may be included in the batch or serial number;
(m) where applicable, method of sterilization. NA The device is not sterile.
13.4. If the intended purpose of the device is not obvious to the user, the manufacturer must A EN980 Instruction of use OK
clearly state it on the label and in the instructions for use.
13.5. Wherever reasonable and practicable, the devices and detachable components must be A EN1041 Label OK
identified, where appropriate in terms of batches, to allow all appropriate action to detect
any potential risk posed by the devices and detachable components.
 File No: TCF-CE-003
Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
13.6 Where appropriate, the instructions for use must contain the following particulars: A OK
EN980 Instruction of use
(a) the details referred to in Section 13.3, with the exception of (d) and (e);
(b) the performances referred to in Section 3 and any undesirable side-effects; A EN980 Instruction of use OK
(c) if the device must be installed with or connected to other medical devices or NA
equipment in order to operate as required for it intended purpose, sufficient details of
its characteristics to identify the correct devices or equipment to use in order to obtain
a safe combination;
(d) all the information needed to verify whether the device is properly installed and can A EN980 Instruction of use OK
operate correctly and safely, plus details of the nature and frequency of the
maintenance and calibration needed to ensure that the devices operate properly and
safely at all times;
(e)where appropriate, information to avoid certain risks in connection with implantation of NA The device needs not
the device; implantation.
(f) information regarding the risks of reciprocal interference posed by the presence of NA The device does intend
the device during specific investigations or treatment to
Specific investigations or
treatment.
(g) the necessary instructions in the event of damage to the sterile packaging and, where NA The device has not sterile
appropriate, details of appropriate methods of re-sterilization; packaging.
(h) if the device is reusable, information on the appropriate processes to allow reuse, NA
including cleaning, disinfection, packaging and, where appropriate, the method of
sterilization of the device to be resterilized, and any restriction on the number of reuses.

If the device bears an indication that the device 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. If in accordance with Section 13.1 no instructions for use
are needed, the information must be made available to the user upon request;

(i) details of any further treatment or handling needed before the device can be used NA The device need not be
(for example, sterilization, final assembly, etc.); sterilized before use.
 File No: TCF-CE-003

Clause Essential Requirements acc. to Annex Ⅰ of the MDD (93/42/EEC) A/NA Standards Documentation OK/Fail
13.6 ( j) in the case of devices emitting radiation for medical purposes, details of the nature, NA The device need
type intensity and distribution of this radiation. not radiation for
The instructions for use must also include details allowing the medical staff to brief the medical purpose.
patient on any contra-indications and any precautions to be taken. These details
should cover in particular:
(k) precautions to be taken in the event of changes in the performance of the device; A EN980 Instruction of use OK
(l) precautions to be taken as regards exposure, in reasonably foreseeable A EN980 Instruction of use OK
environmental conditions, to magnetic fields, external elect
rical influences, electrostatic discharge, pressure or variations in pressure,
acceleration, thermal ignition sources, etc.;
(m) adequate information regarding the medicinal product or products which the device NA
in question is designed to administer, including any limitations in the choice of
substances to be delivered;
(n) precautions to be taken against any special, unusual risks related to the disposal of NA
the device;
(o) medicinal substances, or human blood derivatives incorporated into the device as an NA
integral part in accordance with Section 7.4;

(p) degree of accuracy claimed for devices with a measuring function. NA

(q) date of issue or the latest revision of the instructions for use. A EN980 IFU OK