Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of Regulation (EU) 2017/745

The European Commission has published a Q&A on the transitional provisions applicable to products without an intended medical purpose covered by Annex XVI of Regulation (EU) 2017/745.

This document is intended to facilitate the practical implementation of the provisions set out in Article 2 of Regulation (EU) 2022/2346 (Common Specifications), as amended by Implementing Regulation (EU) 2023/1194 to reflect those set out in Article 120 of Regulation (EU) 2017/745.

It provides stakeholders with a common understanding of the actions required and deadlines to be met to benefit from the amended transitional provisions. This Q&A distinguishes different possible scenarios, in particular those related to the implementation or not of clinical investigation or those applicable to devices covered by a Directive 93/42/EEC certificate.

DOWNLOAD THE Q&A