Team-NB has released a position paper addressing the European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The paper acknowledges that the proposed changes present opportunities to enhance predictability, transparency, and efficiency within the conformity assessment process. Notified Bodies (NBs) broadly support these objectives and recognise that the MDR and IVDR frameworks have already strengthened quality systems, clinical evidence requirements, and regulatory compliance across the medical technology sector.
However, Team-NB highlights several important concerns:
- Incomplete regulatory infrastructure: Core elements of the regulatory framework—particularly EUDAMED and certain Common Specifications—remain unfinished. Implementing further revisions before these foundations are fully operational may create additional uncertainty.
- Risk of reduced scrutiny: Some proposed measures to streamline processes could reduce oversight to levels below those applied under the former Directives. Team-NB cautions that this may have implications for patient safety, public trust, and effective market surveillance.
- Cost-saving assumptions: The Commission’s projected €2.1 billion in cost savings is based on assumptions that, according to Team-NB, do not align with the actual scale of Notified Body revenues. As a result, the estimated savings may not be realistic.
Team-NB supports initiatives that meaningfully reduce administrative burden, foster innovation, and enable earlier and more constructive regulatory dialogue. At the same time, the organisation emphasises that any revisions must preserve robust oversight and maintain the high standards of patient safety established under the current regulatory framework.
The full position paper can be accessed using the following link
