Regulatory Affairs

MDR 2017/745 in force since May 26, 2021

Today, the new EU Medical Device Regulation (MDR) replaces the existing EU Directives (Medical Device Directive, MDD) and the corresponding Swiss medical device legislation enters into effect. When the MDR comes into force, the Swiss medical technology industry will lose its existing barrier-free access to the EU single market. The reason: a prerequisite for the barrier-free trade in goods – namely the updating of the Mutual Recognition Agreement (MRA) – has not been fulfilled to date. The EU had already made it clear in late 2018 that it would neither conclude new bilateral agreements with Switzerland, nor update existing ones, without the Institutional Agreement (InstA) being initialled. This effectively turned the medtech industry into a tactical «ball» in the political game between the EU and Switzerland.


MDR Certification Route

MDR-Classification-route_Class I - III
MDR-Classification-route_Class I - III

Links:

International Medical Device Regulators Forum

imdrf.org

 


Medical Device Regulatory Consulting Access

 

Link Emergo-Group