Medical device CE marking

MDCG issues draft guidance on European nomenclature (2018-2)


According to Article 26 of the Regulation 745/2017 on medical devices and Article 23 of Regulation 746/2017 on in-vitro diagnostic medical device, the Commission is required to make available a medical device nomenclature to support the functioning of the future EUDAMED.

This document intends to provide a detailed description of requirements and criteria that the future nomenclature is expected to fulfil. This is expected to serve as a reference basis throughout the decision process and will also ensure that all legal and technical issues associated with the future EU medical device nomenclature are properly mapped.

The guidance (2018-2) can be downloaded here: library