The European Commission provides a range of guidance documents to assist stakeholders in implementing legislation related to medical devices.
The Medical Device Coordination Group (MDCG) was established by European Union as a group of experts on medical devices. Its members are representing competent authorities of the EU countries. MDCG’s guidance documents assist stakeholders in implementing the Medical Devices Regulation 2017/745.
The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures under Directive 93/42.
These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings
These guidelines are not legally binding. However, due to the involvement of all interested parties (manufacturers, competent authorities, notified bodies etc.) in their development, it is expected that the guidelines to be followed, ensuring the uniform application of relevant directive provisions.
Manual on borderline and classification for medical devices
In certain cases, it may not be clear if a product falls under the medical device legislation or whether to classify a device as a medicine, cosmetic, biocide, personal protective equipment (PPE) etc.
The decision will largely depend on the particular intended use of the product, as assigned by the manufacturer, and on the demonstrated mode of action. The manufacturer’s claims must be substantiated by relevant data (scientific/technical/clinical).
At a European level, decisions made on borderline classification issues relating to medical devices are documented in the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices.