In the last months, several EU organisations expressed their position on the proposed simplification of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). Team-NB, which represents notified bodies involved in conformity assessment, generally supports the objective of improving the regulatory framework but stresses that the revision must be carefully designed to avoid unintended consequences for the sector. Similarly, MedTech Europe welcomes this legislative reform, provided that it delivers a regulatory system “which enhances competitiveness, is efficient, lean and fit for purpose, supports innovation, is well-governed and ensures patients’ access to devices”. Also COCIR, the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries, supports the overall simplification objectives of the proposal.
TEAM-NB: some benefits but also concerns over the MDR and IVDR implementation
According to the position paper, the MDR and IVDR have already strengthened the regulatory system compared with the previous directives by requiring more robust clinical evidence, stronger oversight, and greater transparency. These improvements have increased the reliability of the European medical device framework and contributed to higher standards for safety and performance. Team-NB therefore argues that revisions should build on these achievements rather than weaken them.
The organisation acknowledges that some of the proposed changes could bring benefits. In particular, increased digitalisation and the gradual deployment of EUDAMED are expected to improve transparency and information sharing across the regulatory system. Earlier and more structured dialogue between manufacturers and notified bodies could also make certification procedures more predictable and efficient. In addition, targeted simplifications might reduce unnecessary administrative burdens for manufacturers and facilitate innovation.
However, Team-NB raises several important concerns. One of the main issues is that parts of the MDR/IVDR infrastructure are still not fully operational. Moreover, other key elements of concerns include:
- Risks of reduced regulatory scrutiny
- Need for clarification on core definitions
- Unrealistic assumptions in cost-savings estimations
- Impact on attractiveness for non-EU manufacturers
- Potential negative consequences for EU competitiveness
- Negative implications for notified bodies
MedTech Europe: short-term relief measures are also necessary
MedTech Europe supports the revision and argues that the current regulatory system has become overly complex, slow, and costly. This risks delaying innovation and limiting patient access to medical technologies in Europe. The position paper, which reflects the comments submitted by the organisation in the recent public consultation, calls for a more efficient and predictable regulatory framework while maintaining high standards of safety and performance. MedTech Europe stresses the need to simplify conformity assessment procedures, reduce administrative burdens and improve the capacity and functioning of notified bodies to avoid certification delays.
It also recommends stronger governance and coordination at EU level to ensure consistent implementation of the rules across Member States. In addition to long-term reforms, the organisation suggests short-term measures to stabilise the system, such as faster certification processes and simplified requirements for well-established devices.
COCIR views it as an opportunity to reduce bureaucracy, increase legal certainty, and strengthen competitiveness
In their position paper, COCIR welcomes the European Commission’s proposal to revise the Medical Device Regulation (MDR), noting that the revision addresses challenges encountered during the regulation’s implementation over the past eight years.
The organisation supports the objective of simplifying the regulatory framework while maintaining high standards of patient safety. As political negotiations begin, it calls on EU legislators to ensure that the revised regulation creates a more predictable and efficient certification process, improves centralised oversight of notified bodies, and ensures consistent application of the rules across EU Member States. The organisation also emphasises the importance of supporting innovation through fast-track regulatory pathways, aligning the MDR with other EU legislation, particularly regarding artificial intelligence, and strengthening international cooperation and the faster adoption of harmonised standards. Overall, COCIR views the revision as an opportunity to reduce bureaucracy, increase legal certainty, and strengthen the competitiveness of the European medical device market while maintaining patient safety.
The consultation on the revised MDR and IVDR is still open. Stakeholders can submit their feedback until 6 May 2026 by following this link.
Do you have questions on the revision and how this will impact manufacturers of medical devices and IVDs, contact us here or at mdlaw@obelis.net.
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