MEDICAL TASKS FOR MARKET APPROVAL
The market approval is carried out by means of conformity assessment procedures with the following CE marking. According to the new EU MDR, clinical evaluation plays a much more important role than before. A waiver of a clinical evaluation is not planned. In particular for Class III medical devices and for implantable devices, significantly more stringent clinical requirements for conformity assessment apply according to 2017 EU MDR. This will be done for the clinical part by independent Notified Body Specialists.
The new EU MDR must be applied from 26 May 2020. By 26 May 2020 at the latest, manufacturers must be able to produce an EC certificate under the new MDR when medical devices are first placed on the market.
Clinical Documentation and Clinical Writing
The clinical evaluator Prof. Zenner and Partners can assist the company in the conformity assessment procedure with process-compliant documents and clinical writing.