Switzerland prepared to adopt the MDR

The Swiss Authority for medical devices "Swissmedic" announces the implementation of the first steps towards the harmonization with the new European Medical Device Regulations (EU) 2017/745.

In the past Switzerland accepted CE marked products under the Mutual Recognition Agreement (MRA). This MRA was only valid for the three previous European medical devices directives 90/385/EEC (for AIMD), 93/42/EEC (for MD), 98/79/EC (for IVD). The scope of the MRA needs further alignment with the current legislation which was started now.

 

Swissmedic prepared a statement explaining the current situation concerning the MRA which you will find under the following link.

 

Furthermore the Swiss law on medical devices had to be updated to also address the ne MDR. This link will guide you to the updated swiss "Medical devices Ordinance" (MedDO, english Version) or "Medizinprodukteverordnung" (MepV, german Version).

 

However the complete revision of the MedDo is expected to enter into force by the first half of 2020.

 

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