The TÜV Association welcomes the planned revision of the MDR and IVDR. Positive elements include exemptions for orphan and breakthrough devices as well as stronger exchange between notified bodies. At the same time, several proposals are viewed critically because they would significantly reduce the involvement of notified bodies in certification and surveillance. Fewer audits, reduced technical documentation checks and the removal of unannounced audits would weaken the EU’s high level of safety and increase risks for patients. Mandatory fee reductions for small companies and orphan devices are also seen as problematic, as they could undermine the economic viability of notified bodies. Simplification is appropriate where it improves efficiency without compromising safety. The key objective should be to reduce burden while preserving robust oversight and a high level of patient protection.
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