European Commission under pressure to further revise EU MDR and IVDR

The European Commission is facing renewed pressure from industry stakeholders over the much-delayed and heavily criticised implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). 

At the beginning of September, the Commission opened a call for evidence to simplify EU rules for medical devices and in vitro diagnostics. The request for comments focused on supporting innovation and reducing dependencies while making safety requirements more cost-efficient and proportionate. 

In response, the industry group MedTech Europe and 35 national associations issued an open letter to European Commissioner for Health & Food Safety Olivér Várhelyi calling for “urgent action to secure the availability of medical technologies for European citizens and health systems.”

MDR and IVDR rollout heavily criticized 

In their letter, MedTech Europe and the national associations emphasized the need for “both short-term relief measures and a sustainable, well-structured, well-governed, and well-resourced regulatory framework to improve Europe’s global competitiveness.”

In the long term, the group supports the Commission’s plans to undertake legislative reforms to revise the MDR and IVDR—as long as the changes introduce an efficient, innovation-friendly, and adaptable system. In addition, they highlight the importance of Notified Bodies but call for oversight through a single accountable governance structure that is charged with ensuring efficiency and will keep the EU’s conformity assessment system globally competitive.

The letter also highlights urgent, short-term relief measures that the Commission should implement by the end of 2025 or early 2026. The certification and re-certification process has been a significant sticking point, especially since the lack of Notified Bodies can cause delays. The industry groups call for the Commission to postpone re-certification requirements for devices already certified under the MDR and IVDR. The goal is to keep approved devices on the market and avoid a new major bottleneck for devices transitioning to medical devices rules by 2028.

Other short-term requests include an implementing act that harmonises rules for Notified Bodies. The groups also want the Commission to move forward with its plans to test new expedited regulatory pathways for orphan and paediatric devices and breakthrough innovations.

MedTech European and the national associations were not the only stakeholders who weighed in on the call for evidence—440 other submissions were filed. 

In its comments, the European Federation of Pharmaceutical Industries and Associations (EfPIA) raised concerns that the implementation of the MDR and the IVDR has had “unforeseen effects” on the development of medicines and the initiation of clinical trials in the EU. The group pointed to a 2023 survey it conducted, which suggested that the regulations “are not only blocking access to new treatments for patients with conditions like cancer and rare diseases but also delaying the launch of therapies reaching patients in Europe.”

The U.S.-based Advanced Medical Technology Association (AdvaMed) also provided input,  endorsing MedTech Europe’s proposal for a unified governance structure overseeing the MDR and IVDR. The fact that non-EU entities are offering support adds weight to the proposal and highlights the global impact of amendments to the MDR and IVDR.

Looking ahead

The response window to the call for evidence closed at the beginning of October. The Commission is now reviewing the submissions and plans to provide a response before the end of 2025. The call for evidence itself shows the Commission is willing to consider industry feedback and wants to ensure a reasonable path forward for the regulations. However, it is still unclear what any changes may look like.

The medical device industry should review MedTech Europe’s open letter and other submissions from influential groups, as they may inform the Commission’s ultimate approach to revising the MDR and IVDR. In the meantime, businesses should not pause their current efforts to transition to the new regime. 

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