The Medical Device Regulation (MDR) emphasises the requirement for sufficient clinical evidence for any device to get CE marked. Clinical data are normally needed for being compliant with the general safety and performance requirements (GSPR) of the regulation.
A clinical evaluation is mandatory for all devices and the main output document, the clinical evaluation report, states whether there is enough clinical evidence to support the clinical safety and performance of the device.
Clinical evaluation is on ongoing procedure to collect, appraise and analyse clinical data of pertinence for the medical device. There is a strong relationship between clinical evaluation, risk management and post-market surveillance.
SEK 3 700:- for participants from Swedish Medtech member companies
SEK 5 500:- for non-members
Get a a general knowledge of the requirements on clinical data and clinical evaluation.
Course material will be in English, verbal presentation and discussions in Swedish.