Sailab – MedTech Finland has contributed to the Call for Evidence on MDR/IVDR targeted revisions
Firstly, we would like express our gratitude to European Commission for the opportunity to contribute to this consultation.
Sailab – MedTech Finland, trade association for medical devices (MD/IVD), proposes six short-term measures to simplify EU rules for medical devices and in vitro medical devices.
The six measures are:
- Reduce the administrative burden
- Enhance predictability of the certification processes of notified bodies
- Conformity assessment requirements should be more proportionate
- Further digitalisation is needed
- International cooperation needed to promote competitiveness of the EU medical device sector
- Align MDR/IVDR better with other relevant legislation
Please find below the entire consultation document.
For more information, please contact:
