Clinical Evaluation – Burden or Chance? Workshop on Clinical Evaluation of Medical Devices – Practical Application of MEDDEV 2.7.1 Rev 4 and Medical Device Regulation (2017/745)

This workshop on clinical evaluations of medical devices provides you an overview on the general regulatory requirements according to the MEDDEV 2.7.1 Rev 4 and the Medical Device Regulation 2017/745. In the course of the workshops you will face different challenges implementing a clinical evaluation plan as well as a literature search. Finally, you will bring the information collected during the day together in a draft clinical evaluation report and learn "hands on“ the Dos and Don’ts in preparation of clinical evaluation reports.


  • Regulatory requirements in regards to clinical evaluations
  • Differences and changes from medical device directive to medical device regulation
  • Post market surveillance and post market clinical follow up
  • Clinical evaluation during product lifecycle
  • Clinical evaluation and product development
  • Clinical evaluation and risk management
  • Preparation of clinical evaluation plan
  • Practical implementation of guidance on clinical evaluation plan and literature search
  • Practical implementation of guidance on clinical evaluation reports
  • Pitfalls during preparation and update of clinical evaluations
Target audience: 
The course is best suited for managers and employees that write, review, update and/or take responsibility for clinical evaluations, research and development, regulatory affairs, clinical safety, risk management, quality management.
approx. 10
Basic experience in preparation of clincal evaluations would be an asset but are not a precondition.

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