Our piece earlier this year reported on one such amending regulation on the obligation to notify of supply issues under both the MDR and IVDR which kicked in on 10 January 2025, as well as the public consultation opened by the European Commission at the end of 2024 with a view to a targeted evaluation of both rules. We take a brief look at some key highlights in this space, since then. 

February

In February 2025, the European Commission’s Medical Device Coordination Group (“MDCG”) issued Revision 5 of its document “Questions and answers: Requirements relating to Notified Bodies.” This group was established under the MDR, chaired by a representative of the European Commission and with participants from all Member States. The updated Q&A is required reading for all manufacturers when dealing with notified bodies. Notified bodies are a key part of the medical devices ecosystem in that they are designated to carry out conformity assessment procedures to ensure compliance with medical devices legislation. More generally, the MDCG issues regular guidance and Q&A documents on all aspects of medical device regulation, and whilst not legally binding are considered to be “soft law”. 

March

March saw the closing date for the European Commission consultation which opened at the end of 2024.  

MedTech Europe, the European trade association for medical technology industries, which represents a wide range of members, has prepared detailed materials around overall reform of the regulatory landscape for medical devices. MedTech Europe has called out speed, unpredictability, cost, complexity, and lack of agility as matters which should be addressed and which it feels are not where they ought to be after almost eight years of the coming into law of the regulations. In its March response to the recent consultation, three areas for action were identified by MedTech Europe: (i) an efficient regulatory system (ii) an innovation-friendly regulatory system (iii) a well-governed regulatory system. It has also prepared a detailed “Report on the Administrative Burden” under MDR and IVDR.  

March also saw the publication of Irish Medtech’s (part of IBEC) Medtech Sector Manufacturing Report, with one of the calls on the government accompanying publication, being the prioritisation of AI and automation in the promised National Life Sciences Strategy. 

The European Medicines Agency (“EMA”) published an interim report on its pilot programme on an expert panel on high-risk medical devices. This pilot gave access to manufacturers, via a dedicated regulatory procedure, to experts. The report noted that a high proportion of proposals were presented by SME manufacturers. How this project continues to evolve will be something to monitor keenly. 

Finally, Team– NB, the European Association of Medical Devices Notified Bodies, issued a statement encouraging all members to “continually consider the possibility of issuing certificates with specific conditions, provisions, or limitations to ensure that innovative, novel and orphan medical devices continue to be accessible to healthcare professionals and patients in the EU with appropriate surveillance safeguards in place”, which is possible pursuant to the MDR and IVDR and was the focus of a 2024 CORE-MD report.

April

The current geopolitical landscape and the introduction of tariffs by the US Government have impacted the medical devices sector and the situation continues to evolve. On 29 April, MedTech Europe published an open letter to the European Commission highlighting the acute repercussions facing the sector due to tariffs. 

Team–NB published a number of guidance documents of importance to manufacturers, notified bodies and other stakeholders in April, including: 

• a revised version of its Best Practice Guidance for the submission of Technical Documentation under the MDR. This third revision includes updates on clinical evaluation, post-market surveillance and common pitfalls observed by notified bodies; 

• a position paper on the certification process under the IVDR, which applies to both legacy IVDs and IVDs that are new to the market, and provides detailed guidance on the pre-application, application and post-application phases for manufacturers seeking certification under the IVDR; and 
• a revision of its position paper on the European AI Act, which highlights the challenges of implementing the AI Act, particularly in the context of its overlap with the MDR and IVDR, and calls for a coordinated approach to ensure efficient conformity assessments for high-risk medical device AI systems. 

May

The rolling transitional provisions under both the MDR and the IVDR continue to be in play. One upcoming date is 26 May 2025 which applies to aspects of both types of medical device. Manufacturers should seek advice if unclear as to which transitional arrangements apply and when, as it will very much depend on the type of device, the form of certification sought and several other potential factors 

With the position on tariffs, the calls by industry for reform and the outcome of the recent consultation awaited, there are some shifting and unpredictable conditions for those operating in the medical devices sector.

For further information, please contact our Life Sciences Group.