The UK government recently released the text of a new draft statutory instrument (SI) which will update the post-market surveillance (PMS) rules for medical devices in Great Britain. The draft SI became public as a result of its notification to the World Trade Organisation (WTO) and can be found on the WTO's website here.
The UK is introducing these new rules on PMS in the context of an ongoing revamp of the UK's medical device regulatory framework following its exit from the European Union.
Based on the UK's notification to the WTO and the MHRA's updated guidance regarding the introduction of the new regulatory framework, the draft SI will be laid before Parliament in December 2023 and enter into force in June 2024.
The draft SI will amend the UK's Medical Devices Regulations 2002 (UK MDR) to introduce the new PMS rules. The new PMS rules will only apply to medical devices placed on the market in Great Britain, as Northern Ireland remains subject to the EU regulatory framework under the Northern Ireland Protocol.
Manufacturers should start paying attention to this text now. It appears that manufacturers will need a dedicated UK MDR-compliant PMS system for all medical devices which are placed on the market in Great Britain from June 2024.
Fortunately, it appears that the new PMS requirements substantially mirror those which already exist in the EU Medical Device Regulation 2017/745 (EU MDR) and In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR), save that PMS documentation will need to be retained for a much longer period of time under UK MDR. As most manufacturers of medical devices will already operate PMS systems which are compliant with EU MDR and IVDR, this will make developing a PMS system for UK MDR much easier.
Nonetheless, manufacturers need to ensure that their documentation is ready and that they understand their PMS regulatory obligations for medical devices in Great Britain. In particular, manufacturers should understand when it is necessary to report matters to the Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers should also be alive to the potential challenges of addressing safety signals for medical devices in Great Britain which are received pre-June 2024 and are still in process post-June 2024 when the new PMS rules apply.
The World Trade Organisation (WTO) published notification of the draft Post-market Surveillance Requirements Statutory Instrument (PMS SI) on 26 July 2023. WTO members have 60 days to comment to the Department of International Trade.
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