UK MHRA Updates Roadmap for New Medical Device Regulations

By Karen Hill and Evangeline Loh

The MHRA presented a webinar on the UK Medical Devices Regulations on January 24, 2023. The webinar featured the staff of the MHRA updating on the current regulatory background; expected dates of future statutory instruments (SI); the role of the focus groups in developing additional guidance; the status of Approved Bodies (AB); as well as “ensuring continuity of supply of devices,” followed by an extensive Q&A session. The MHRA highlighted patient safety and benefit, “need for patient safety and being supportive in an operating environment to support industry and patients,” mentioned international harmonization and the International Medical Device Regulators Forum (IMDRF) in reference to the Software and Artificial Intelligence Roadmap from October 2022 “legislatively light changes,” and in the context of Abs, a “pragmatic and flexible approach.”

While the updates were not necessarily new, a synopsis of the session follows:

• The Life Sciences Council Advisory Group (members: MHRA, Association of British HealthTech Industries (ABHI), Department Health and Social Care (DHSC), office Life Sciences) has prioritized a proposal for international recognition. From the MHRA slide: “domestic assurance routes that will allow recognition of approvals in other, trusted jurisdictions (e.g., the US Food and Drug Administration (FDA)) and immediately release capacity constraints”.  During the Q&A, it was added that the MHRA is also exploring countries that form part of the IMDRF. As part of this initiative, the MHRA is conducting gap analysis of other legislation with “patient safety at the heart of what we do,” and that the regulator “may do different things with different classifications.” This concept of “Alternative Routes to market- Domestic Assurance” was also highlighted as part of the future Medical Devices Regulation (MDR). (Note the reference to future MDR is not to be confused with the EU Medical Devices Regulation (EU) No. 2017/745.). There was also mention of an Innovative Devices Access Pathway (IDAP) that allows manufacturers to provide innovative medical technologies at the earliest, safe, opportunity.

• Three SIs are expected: Transitional arrangements, Post-market Surveillance (PMS), and Future MDR.
  • Transitional arrangements (expected Spring 2023; implementation date immediate effect) amend the end of the standstill date (June 30, 2023) in UK MDR 2022 and introduce transitional arrangements for CE marked devices.
  • PMS (expected summer 2023, implementation winter 2023/early 2024 with a six-month implementation period) bring into force new PMS requirements for CE marked and UK Conformity Assessment (UKCA) marked devices as laid out in a June 2022 government response to public consultation.
  • Future MDR (expected winter 2023, implementation summer 2024 with a six-month implementation period) will bring into force wider MDRs as laid out in government responses to public consultation.

• On the topic of the PMS SI, MHRA presenters emphasized that there is/will be a fair amount of alignment with the EU legislation related to PMS, and an example was the same timeline for reporting serious adverse events. Topics which would be part of the PMS SI:
  • More stringent PMS requirements;
  • Tighter timelines for reporting adverse incidents;
  • Details on what should be covered in a PMS plan/PMS systems;
  • Requirements for health institutions;
  • Requirements for custom-made devices; and,
  • Details on what should be covered in trend reports and field safety corrective action (FSCA).

• Guidance is expected to be published to accompany the SIs, and the first guidance would cover PMS. Focus groups, made up of 10-15 participants (one to two representatives from Trade Associations, ABs, Devolved Administrations, in-house experts and patient representatives) have been tasked for a six-to-eight-month period to develop the guidance.
• There are currently four ABs with different designations. There are six more ABs in various stages of applications. While the designation process is lengthy (six stages) and the ABs must comply with the MDR 2002 and Commission Implementing Regulation (EU) No 920/2013, the MHRA advanced a “pragmatic and flexible approach” and purported that the timeline was shorter than the estimated 20 months for EU Notified Bodies. There are no bodies currently designated for Northern Ireland to issue UK Northern Ireland (UKNI) marking. ABs already designated to UK MDR 2002, will not be required to redesignate to the future MDR.
• For IVDs, the MHRA opined on five strategic themes. A roadmap for IVDs was estimated to be with the board in March or April of 2023, with publication in May, or at the latest the summer of 2023.

Karen Hill is Manager, Quality and Regulatory Affairs Program and Evangeline Loh is Global Manager, Regulatory Affairs at Emergo by UL.