With the new EU Medical Devices Regulation (EU MDR 2017/745) in place, manufacturers of medical devices of all risk classes are required to carry out clinical evaluations. This is binding for manufacturers of medical devices and also applies after market entry of the medical device (Article 10, Paragraphs 3 and 9f MDR) as part of the quality management. By definition, this is a systematic process in which compliance with the essential safety and performance requirements is demonstrated and where undesirable side effects are excluded. Furthermore, it has to be demonstrated that there is a justifiable benefit-risk ratio.
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.
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