The introduction of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR) comprises the first stage in a complete overhaul of the current UK regime for the regulation of medical devices (the Medical Device Regulation 2002 (UK MDR)).
An initial draft of PMSR was published by the MHRA in August 2023 (2023 Draft) to comply with the UK's obligations to the World Trade Organisation (WTO) under the Agreement on Technical Barriers to Trade. We wrote about the key requirements set out in the 2023 Draft at the time. The provisions of PMSR reflect those in the 2023 Draft, with only minor and clarificatory amendments introduced by the MHRA.
The UK's PMS requirements will closely mirror the EU requirements under the EU Medical Device Regulation 2017/745 (EU MDR) and EU In Vitro Diagnostic Medical Device Regulation 2017/746 (EU IVDR), with the introduction of similar requirements for:
- the systems manufacturers are required to maintain, including the PMS system and PMS plan;
- the reports manufacturers must publish, i.e. the PMS report for low risk classes of device and periodic safety update report for higher risk devices; and
- manufacturer's obligations following a serious incident involving a medical device or IVD.
PMSR has been long-anticipated by industry following an initial consultation by the MHRA in 2021. In 2023 the MHRA announced its intention to take a phased approach to reforming UK MDR, starting with the reforms to the post-market and vigilance requirements set out in PMSR.
Once the PMSR has completed the UK's parliamentary process and passed, it will be subject to a six month implementation period. Industry can therefore expect the reforms to take effect in summer 2025 at the earliest. The MHRA intends to publish guidance for medical device manufacturers on the PMSR requirements in advance of implementation.
Authored by Jane Summerfield, Bonella Ramsay, and Bea Watts.
