Article 5
1
Conformity assessment procedures for medical devices referred to in Article 1(1) shall include the evaluation of compliance of the devices with the essential requirements of Part 3 or Part 2 of the Medical Devices Regulations 2002, respectively, and the particular requirements laid down in Annex I to this Regulation.
2
Approved bodies shall assess the documentation submitted by the manufacturer to verify that the benefits of the device outweigh the residual risks. Particular account shall be taken of:
a
the manufacturer’s risk analysis and risk management process;
b
the justification for the use of animal tissues or derivatives, taking into consideration lower risk tissues or synthetic alternatives;
c
the results of elimination and inactivation studies or results of the analysis of relevant literature;
d
the manufacturer’s control of the sources of raw materials, finished products, production process, testing, and subcontractors;
e
the need to audit matters related to the sourcing and processing of animal tissues and derivatives, processes to eliminate or inactivate pathogens, including those activities carried out by suppliers.
3
Approved bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter ‘TSE certificate of suitability’, for starting materials, where available.
Where additional information is necessary to assess the suitability of the starting material for a given medical device, approved bodies may require submission of additional information to allow the evaluation as set out in paragraphs 1 and 2.
4
Before issuing a design-examination certificate or a type-examination certificate the approved body must inform the Secretary of State of their assessment carried out pursuant to paragraph 2 by means of a summary evaluation report in accordance with Annex II to this Regulation.
5
The Secretary of State may submit comments on the summary evaluation report referred to in paragraph 4 within the following deadlines:
a
in relation to medical devices using starting materials for which a TSE certificate of suitability as referred to in paragraph 3 has been submitted, within four weeks from the date on which the approved body informed the Secretary of State pursuant to paragraph 4;
b
in relation to medical devices using starting materials for which a TSE certificate of suitability has not been submitted, within 12 weeks from the date on which the approved body informed the Secretary of State pursuant to paragraph 4.
6
The approved bodies must—
a
give due consideration to any comments received in accordance with paragraph 5;
b
provide an explanation as regards this consideration, including any due justification not to take account of one or more of the comments received, along with their final decisions to the Secretary of State.
7
The manufacturer shall collect, evaluate and submit to the approved body information regarding changes with regard to the animal tissue or derivatives used for the device or with regard to the TSE risk in relation to the device. Where such information leads to an increase of the overall TSE risk, the provisions of paragraphs 1 to 3 are applicable.
Words in Art. 5(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 12(a)
Words in Art. 5(2) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 12(b)
Words in Art. 5(3) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 12(c)(i)
Words in Art. 5(3) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 12(c)(ii)
Words in Art. 5(7) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 12(e)(i)
Words in Art. 5(7) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 12(e)(ii)
Art. 5(4)-(6) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 12(d)