Team-NB: Opportunities and Concerns in the MDR/IVDR Revision
Team-NB, the European association of medical device Notified Bodies, sees the proposed MDR and IVDR revision as an opportunity to improve efficiency, transparency and predictability in conformity assessment. Positive elements include increased digitalisation of technical documentation, the use of EUDAMED and remote audits, and stronger early regulatory dialogue between manufacturers, Notified Bodies and expert panels. Measures to support innovation, such as regulatory sandboxes and dedicated pathways for orphan or breakthrough devices, are also welcomed.
At the same time, Team-NB expresses concerns that several proposed changes could reduce regulatory scrutiny, for example through fewer audits or reduced review of technical documentation. According to the organisation, this could ultimately affect patient safety and confidence in the regulatory system.
The association also considers the European Commission’s estimated €2.1 billion cost savings unrealistic, given that the total annual revenue of all Notified Bodies combined was €475 million in 2024.
Source:
Team-NB: Position Paper - MDR/IVDR revision: impact on the sector
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
