Introduzione
The classification of medical devices in the EU is set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR) and in the recently published MDCG Guidance (MDCG 2021-24).
The classification of a product as device and specific risk class has practical relevance for the market access strategy, the research and development, the conformity assessment procedure and data prerequisites in the pre-clinical, clinical and manufacturing module of the technical dossiers as well as the labelling, post market and traceability requirements.
This course is dedicated to the detailed understanding on the legal basis and guidance of the classification logic, the medical device definition, how to carry out classification, which procedure to follow for classification requests with notified bodies or competent authorities and the practical regulatory relevance of classification on the technical documentation and the conformity assessment process.
The course will give typical examples for each classification rule and will focus on borderline products such as medical device software, substance-based devices, injectable devices and device-drug combinations.
