Module 16 2024

24/10/2024

UK Medical Devices Regulations Current requirements

The Medical Devices Regulations 2002 (SI 2002 No 618, as amended)(UK MDR 2002)

Amended by EU Exit Legislation Schedule 2A

Current legislation

Part II: general medical devices

MDD 93/42/EEC

Great Britain

UK Marking (UKCA)

UK Approved Body

EU Notified Body

CE Marking

Part III: active implantable medical devices Part IV: in-vitro diagnostic medical devices

AIMDD 90/385/EEC

IVDD 98/79/EC

UK Designated Standards

UK Responsible Person

EU Harmonised Standards

EU Authorised Representative

Northern Ireland

EU MDR & IVDR apply

The role and responsibilities of ABs & NBs in PMS & V

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UK MDR 2002 PMS & V requirements - current ( and EU Medical Devices Directives)

Annex II, IV, VI, VII an undertaking by the manufacturer to institute and keep up todate a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them

Annex X 1.1c The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

Manufacturer to provide, and where applicable AB to asses … the data stipulated in the part of the quality system relating to design……. such as the results of ……pre -clinical and clinical evaluation, post-market clinical follow up plan and the results of the post-market clinical follow-up, if applicable, etc

No specific requirements for AB to assess vigilance incidents Provision and assessment of incident reports often covered in AB T&Cs

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

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