According to the MEDDEV guideline 2.7.1 (June 2016), the EU regulation 2017/745 (MDR) again tightened the requirements for clinical evaluations. For a large number of products, the method of equivalence that was often used up to now is no longer possible. In addition, the topic of PMCF will be legally binding for the first time. Benefit from our experience from a large number of interactions with notified bodies and authorities.
In all processes, we always inform you about progress and problems so that a timely finalization can be realized. You are in direct contact with the author of the clinical evaluation.
In addition, we also offer a seminar on the subject of "Clinical evaluations of medical devices". In this seminar, supported by practical exercises, you will learn the basics and regulatory requirements for the proper preparation of a clinical evaluation in accordance with the current MEDDEV guideline, the MDR and the MDCG documents (Flyer).