On December 16, 2025, the European Commission published a proposal to revise the existing EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The aim is to simplify the rules, reduce the administrative burden, and provide manufacturers with clearer, more efficient, and digitalized procedures. It also seeks to create greater predictability in the conformity assessment process.
Key changes at a glance
- Adaptation of classification rules for medical devices and in vitro diagnostic medical devices
- Streamlining of certain documentation requirements
- Increased use of digital tools for manufacturing and conformity assessment processes
- Removal of the maximum validity period for certificates – instead, risk-based, regular reviews by Notified Bodies
Manufacturers and interested parties can provide feedback on the proposal until May 2026.
Further information can be found on the European Commission’s website.
The European Association of Medical devices Notified Bodies (TEAM-NB) has published a position paper in response to the European Commission’s proposal.
Revised fees of SGS Fimko Oy
In this context, the updated fees of the Notified Body SGS Fimko Oy (CE 0598) have been published. Download.
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