Following the recent signature of the EU–Switzerland agreement package, MedTech Europe, Swiss Medtech and SVDI have issued a joint statement welcoming the signature and highlighting the importance of updating the medical devices chapter of the Mutual Recognition Agreement (MRA) for the medical technology sector.
As many of you will know, the MRA enables mutual recognition of conformity assessment procedures, allowing medical devices certified in one market to be accepted in the other without duplicative regulatory processes while maintaining high standards of safety and quality.
When the EU Medical Device Regulation (MDR) entered into application in 2021, the medical devices chapter of the MRA was not updated to reflect the new regulatory framework. As a result, mutual recognition for medical devices between the EU and Switzerland no longer applies in practice and companies on both sides have faced additional regulatory and administrative requirements when placing medical technologies on the respective markets.
Updating the medical technology chapter of the MRA therefore represents an important step towards reducing regulatory duplication and improving the efficiency of the highly integrated medtech supply chains as well as supporting timely access to safe and innovative medical technologies for patients and healthcare systems across both markets.
