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.

The seminar is intended for professionals of the medical device industry dealing with class III (high risk) products and implantables: Personal of Clinical Affairs, Regulatory Affairs, Quality Management and others involved in the Clinical Evaluation. This is not a seminar for beginners.

• Clinical Evaluation – Key Requirements
• MDCG guidance documents
• Validity of MEDDEV 2.7/1 Rev.4
• Expectations of a NB
• Clinical evaluation plan (CEP)
• Critical aspects and pitfalls in a CER
• The equivalence problem

Participant discount: From the 2nd participant you will receive a discount of 15% and from the 5th participant 25% on the net price.

Customer discount: mdc customers receive a 10% discount on the net price.

Participant and customer discounts cannot be combined!

The discount will be deducted automatically if a booking concerns employees of the same company and the same seminar.

Please note that the registration fee and the associated participation only applies to one person. If several people take part in the remote-seminar, although only one person has registered, we reserve the right to exclude the further persons from the seminar.

450.00 Euro (plus value added tax)