Overview
Commissioner Olivér Várhelyi Outlines His Priorities
In a recent interview Commissioner Olivér Várhelyi outlined his main priorities for EU health policy. He believes that the EU’s competitive must bolstered. A proposal for a Biotech Act and completion of the revision of the Pharmaceutical legislation are, consequently, important priorities for him. The proposal for a Biotech Act is part of the Communication on Building the future with nature published by the European Commission in 2024. An assessment of how EU legislation and its implementation could be further streamlined to reduce fragmentation, explore potential simplification, and shorten the time to market for biotech innovations is intended to lay the foundations for the proposed Act. Commissioner Várhelyi also confirmed his previously stated intention to propose a Critical Medicines Act within the first 100 days of his new mandate, a measure that he considers critical to boosting the EU's economic security and to ensuring European citizens’ health. Preventive health is also a priority for Commissioner Olivér Várhelyi. He intends to create a European Cardiovascular Health Plan, similar to the current Beating Cancer Plan but more operational.
European Commission Considers Next Steps Following the, Sometimes Harsh, Comments Provided in Responses to the Consultation Process on the MDR and IVDR
The provisions of the Medical Devices Regulation (MDR) and the in vitro diagnostics Regulation (IVDR) require the European Commission to assess the application of the Regulations and produce an evaluation report on the progress towards achievement of their objectives by May 2027. In light of the multiple issues that have been identified in relation to the Regulations the Commission decided, however, to launch a targeted evaluation in 2024. One risk related to a request for opinions is that one is likely to receive challenging responses. The European Commission’s three-month public consultation on the MDR and the IVDR has resulted in some harsh criticism. Some respondents included constructive proposals such as suggestions for simplification of the conformity assessment process for low-risk products, and clarity concerning notified body fees and timelines. However, other respondents expressed concerns that the Regulations were stifling innovation and could lead to product shortages or encourage manufacturers to leave the EU. There were a number of particularly harsh comments, including description of the Regulations as “a mess” or “at best, a disaster”. It is unlikely that any of the comments came as a surprise to the Commission. It is, however, as yet unclear what related proposals the Institution will make, including whether these will reflect the proposed revisions to the MDR that have been prepared by the European Parliament.
MDCG 2023-3 Q&A in Vigilance Terms and Concepts in the MDR and IVDR Updated
MDCG has published MDCG 2023-3 Rev.2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The guidance provides advice concerning vigilance obligations related to medical devices and in vitro diagnostic devices governed by the MDR and IVDR. The fact that the guidance applies to medical devices falling within both the Medical Devices Regulation (MDR) and the IVDR has been underlined along with related examples. Among the helpful updates in Revision 2 are clarifications to the scope of the terms “incident” and “serious incident”, the circumstances in which each term should be considered to apply, and the criteria to be applied for reporting serious incidents arising in relation to devices falling within the scope of the Regulations. Among the practical additions are guidance concerning when “manufacturer awareness” is considered to have occurred and what is to be considered “use errors”.
EMA Updates and Strengthens Policy on Conflicts of Interest
The European Medicines Agency (EMA) has recently published an update to the Agency’s Policy on conflicts of interests of members of scientific committees and experts. The updated policy, which will apply from May 2025, is a result of a recent decision of the Court of Justice in Joined Cases C‑6/21 P and C‑16/21 P and Case C-291/22 P which required the EMA to adjust certain aspects of its approach. The updated Policy means that, where experts have a current interest in a product, they will be excluded from procedures related not only to the product concerned but also for products in the same declared condition. Experts who play the role of principal investigator and investigator will be subject to the same restrictions. Rules requiring a three year cooling off period related to past employment in a pharmaceutical company that already apply to members of Committees will now also apply to experts who may be brought into the assessment process on an ad-hoc, consultative basis to provide their input on specific points. Reflecting the EMA’s increasing role in the medical device industry, individuals involved in EMA activities cannot be current employed by, nor may they provide consultancy or strategic advice on general matters and financial interests to the medical device industry.
MHRA Develops Guidance on New Medical Devices Post-Market Surveillance Requirements
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a sheaf of guidance documents intended to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. The guidance documents are intended to provide support for medical device manufacturers navigating the new Medical Device Regulations that will come into force on 16 June 2025. The Regulations will facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues and reducing harm. The Regulations and guidance will apply in Great Britain (England, Wales and Scotland). Medical devices placed on the market or put into service in Northern Ireland (NI) will, however, continue to comply with the post-market surveillance rules set out in EU medical devices regulations. These rules are presented in guidance on the Regulation of devices in Northern Ireland.
