On the 18th July, the EU Commission published its updated Q&A document on the practical aspects related to the implementation of Regulation (EU) 2023/607 as regards the transitional provision for certain medical devices and in vitro diagnostic medical devices. We had mentioned this in our recent newsletter and it has been posted on our website. However, within this document was a small mention of the harmonised self-declaration template that the EC Commission has released with links in the footnotes.
Since this document is now available we would advise all clients (even non-clients) to make use of this document in place of the template previously offered by Advena some months ago, at a time when the EU Commission did not make one available. This new template will provide a harmonised approach to self-declaring your devices meet the criteria that make them eligible for the extension.
The harmonised manufacturers self-declaration template can be downloaded here: [SD Template]
