To the attention of manufacturers, authorised representatives, economic operators and all interested stakeholders
Please be informed that on 18 July 2023 the European Commission has published the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, REV. 1.
The purpose of this Q & A Guideline is to facilitate the enforcement of Regulation (EU) 2023/607.
In Rev. 1 of the guideline, new questions were added and some questions from the initially published guideline were modified/supplemented.
The announcement is available online on the website of the European Commission:
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