Essential Requirement Checksheet - FC161
Essential Requirement Checksheet - FC161
4. The characteristics and performances referred to in Section 1, 2 and EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
3 must not be adversely affected to such a degree that the clinical
conditions and safety of the patients and, where applicable, of other
A
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 condition of use.
5. The device must be designed, manufactures and packed in such a EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
way that their characteristics and performances during their intended 7.2.17, 7.9.3.1, 15.3.7
use will not be adversely affected during transport and storage taking A EN ISO15004-1:2009 Test Report No.1404-9A
account of the instructions and information provided by the ISO9022-3:1998
manufacturer. JIS Z0200:1999
6. Any undesirable side-effect must constitute an acceptable risk EN ISO14971:2012 Risk Management File
when weighed against the performances intended. A
6a. Demonstration of conformity with the essential requirements must MEDDEV2.7.1 Rev.4 Clinical Evaluation Report
include a clinical evaluation in accordance with Annex X. A
7.3 The device must be designed and manufactured in such a way that EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
they can be used safely with the materials, substances and gases with 11.6.1, 11.6.6
which they enter into contact during their normal use or during routine
procedures; if the devices are intended to administer medicinal products
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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
performances is maintained in accordance with the intended use.
7.4 Where a device incorporates, as an integral part, a substance Such substance is not incorporated.
which, if used separately, may be considered to be a medical 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 NA
designated by the Member States or the European Medicines Agency
(EMEA) acting particularly through its committee in accordance with
Regulation (EC) No 726/2004 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.
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Where changes are made to an ancillary substance incorporated in a Ancillary substance is not incorporated.
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 device must be designed and manufactured in such a way as to There is no substance leaking from the device.
reduce to a minimum the risks posed by substances leaking from the NA
device.
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If parts of a device (or a device itself) intended to administer and/or The device is not intended to administer or remove
remove medicines, body liquids or other substances to or from the medicine, body liquid or other substance to or from
body, or devices intended for transport and storage of such body fluids body.
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 labelled
on the device itself and/or on the packaging for each unit or, where
appropriate, on the sales packaging as a device containing phthalates.
8.3 Devices delivered in a sterile state must be designed, manufactured There is no part delivered in a sterile state.
and packed in a non-reusable pack and/or according to appropriate
procedures to ensure that they are sterile when placed on the market NA
and remain sterile, under the storage and transport condition laid down,
until the protective packaging is damaged or opened.
8.4 Devices delivered in a sterile state must have been manufactured There is no part delivered in a sterile state.
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and sterilized by an appropriate, validated method.
8.5 Devices intended to be sterilized must be manufactured FC-161 is non-sterile device.
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inappropriately controlled (e.g. environmental) conditions.
8.6 Packaging system for non-sterile devices must keep the product EN ISO13485:2016 Package Drawing
without deterioration at the level of cleanliness stipulated and, if the
device are to be sterilized prior to use, minimize the risk of microbial A EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
contamination; the packaging system must be suitable taking account of 7.2.17
the methods of sterilization indicated by the manufacturer.
8.7 The packaging and/or label of the device must distinguish between The device is not sold in both sterile and non-sterile
identical or similar products sold in both sterile and non-sterile NA condition.
condition.
9. Construction and environmental properties
9.1 If the device is intended for use in combination with other devices or The device is not intended for use in combination
equipment, the whole combination, including the connection system with other devices.
must be safe and must not impair the specified performances of the NA
devices. Any restriction on use must be indicated on the label or in the
instructions for use.
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If the device bears an indication that the device is for single use,
information on known characteristics and technical factors known to the
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(i) details of any further treatment or handling needed before the device
can be used (for example sterilization, final assembly, etc);
(j) in the case of devices emitting radiation for medical purpose, details
of the nature, type, intensity and distribution of this radiation.
The instruction for use must also include details allowing the medical
staff to brief the patient on any contra-indication and any precautions to
be taken. These details should cover in particular: