The innovations in the EU Medical Device Regulation (EU MDR 2017/745) could, if implemented strictly, result in the fact that equivalence of comparable products will no longer be recognised. In this case, own clinical investigations must be carried out before placing the product on the market. In addition, clinical data must also be collected, documented, and evaluated after the products have been placed on the market. For medical devices in risk class III, this becomes the rule with only a few exceptions. Clinical investigations will also be necessary for new medical devices included in the MDR.
We are already working on adapting our processes to the EU Medical Devices Regulation (EU) 2017/745, which will apply from 26 May 2020.
The main changes brought about by MDR:
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