When conducting the clinical evaluation for a medical device the authorship often poses questions about the interpretation of the new MDR.

• What are the key requirements which need to be addressed in a clinical evaluation?
• What are the NB’s expectations with regard to a clinical evaluation report?
• What are critical aspects and which pitfalls may encounter in a clinical evaluation report?

The collection of clinical data in the conformity assessment process is crucial to assess a medical device in terms of safety, performance and risk-benefit ratio. They are based on the actual use of the device and are composed of pre-clinical or clinical investigations, scientific literature and/or clinical experience with equivalent medical devices. These requirements are detailed in the EU regulation 2017/745 (MDR) for medical devices.

Our Speaker, Dr. Andreas Marx, head of the clinical department at mdc, will convey critical aspects of the clinical evaluation process. This encompass the interpretation of key requirements of the MDR, applicable MDCG guidance documents and parts of the MEDDEV 2.7/1 rev.4 which are still of relevance.

In Part II our Speaker, Dr. Andreas Marx, head of the clinical department at mdc, will discuss critical aspects of additional documentation which is under clinical review such as the IFU, PMCF plan and the SSCP.