The MHRA consultation on the future regulation of medical devices and in-vitro diagnostic devices in the United Kingdom shed light on the potential PMS requirements that become effective in the UK. Based on the responses, the government mentioned proceeding with the intention to amend the UK MDR 2002 (SI 2002 No 618, as amended) to clarify and strengthen the PMS system for manufacturers.
On July 26th, the draft Statutory Instrument for post-market surveillance, (Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023) was notified to the World Trade Organization which further amends the UK MDR 2002 to introduce clearer, risk-proportionate PMS requirements, with improved regulatory oversight. Whilst the UK MDR 2002 included high-level provisions around PMS and vigilance activities, most details were provided through additional guidance documents – in line with the EU guidance documents. By clarifying and strengthening the PMS and vigilance requirements through the amended Statutory Instrument, the MHRA aims to achieve more consistency for manufacturers in their PMS activities and to improve the quality of the adverse incident data reports. This is in line with the government’s response showing that most respondents were in favor of outlining the elements required in the PMS documentation.
Manufacturers often ask when PMS activities start to apply. The Statutory Instrument has defined a PMS period as:
a) the period beginning with the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner, and
b) the period ending with the end of the lifespan of the last device of that device model that is put into service by the manufacturer or placed on the market, whichever is later.
Throughout this defined PMS Period, all PMS obligations must be diligently carried out. This includes creating a comprehensive PMS plan, and where applicable, a PMS report or Periodic Safety Update Report (PSUR). The timelines for PSURs are comparable to those of the EU MDR/IVDR, respectively required every year or every two years depending on the risk class. For Class I (MD) or Class A/B (IVD) devices, the PMS report must be updated every three years until the end of the PMS period for the device model.
Furthermore, enhancements to the look and feel of the new MORE portal have started. The portal is introduced for adverse incidents and vigilance reporting. The transition to the new MORE portal will be fully effective as of 31st August 2023. Based on the feedback from user experience, the government is working on improvements to the portal for easier reporting and better management of open reports. The legacy MORE portal is now read-only whilst manufacturers have until 31 August 2023 to report directly through the AICxml mailbox. However, manufacturers are encouraged to start any new report through the MORE portal for the sake of accessibility and traceability.
Future improvements are planned on the assignment of email notifications, PDF versions of submitted reports, and improvements to the language.
Although we cannot assume that all the requirements to the post-market surveillance system and vigilance system are the same as those of the EU MDR and IVDR, there are similarities that will allow manufacturers better monitoring and maintenance of meeting these requirements.
Useful links:
WTO Notification
Draft Statutory Instrument on PMS