ACIG

20 Clinical evaluation according to MDR Annex IV and its relationship to surgical instruments Background to clinical evaluation The new EU directive for medical products (Me- dical Device Regulation – MDR 2017/745) has been in force since 25 May 2021. New products must be approved accor- ding to this directive and can no longer be marke- ted according to the ‘old’ guideline, 93/42/EEC. It is not just since the new EU-MDR was introduced that clinical evaluati- on has been a standard component of technical documentation, and therefore mandatory for every medical products manu- facturer. Clinical evaluation was already mentioned in the 93/42/EEC gui- deline (the MDD) and explained there. However, a search for the keyword ‘clinical evaluation’ in both documents, the MDR and MDD, clearly shows the major extent to which this has concept has been foregrounded in the new regulation: in the MDD it turns up 9 times, in the MDR there are as many as 59 matches. Article 2, para. 44 of the MDR reads as follows: ‘”Clinical evaluation” means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as in- tended by the manufacturer.’ A clinical evaluation is therefore a systematic search and analysis of the available specialist literature and other data in order to demonstrate that the product meets the requirements of safety and performance. Its aim its to indicate the clinical benefits and, by so doing, already demonstrate that the product does not entail any increased risk. In this context, ‘increased risk’ means that the risk-benefit ratio turns out to be positive, in other words, that the benefits exceed the risks. And here we already come up against ENGLISH Authors: Dr. Wolfgang Sening, CEO Dr. Patrick Hansmann, Deputy Head Regulatory Affairs & Quality Management senetics healthcare group GmbH & Co. KG Hardtstraße 16, 91522 Ansbach, Germany E-Mail: info@senetics.de , Web: www.senetics.de