The French National Agency for Medicines and Health Products Safety (ANSM) recently published a Q&A providing guidance for medical device and in vitro medical device manufacturers headquartered in France in case their notified bodies ceased operations, either voluntarily or following a denotification decision by the competent authority.
The Q&A is particularly helpful in the absence of any regulatory provisions concerning the consequences of a notified body denotification on medical device manufacturers, and is in line with the guidelines for managing situations created by notified body denotifications that were agreed on at the October 2016 meeting of the EU competent authorities for medical devices.
In particular, the Q&A provides that:
- A manufacturer with valid CE certificates at the time of its application with a date of validity subsequent to that of the denotification of the notified body, can continue to market the concerned device(s) until the end of the initial period of validity of the certificates and in all instances within a maximum limit of 12 months following denotification or the effective end of activities of the notified body. The principle applies under certain conditions, including in particular the identification of the new notified body, evidence that the certification process has been initiated and the anticipated date that it will be finalised. The audit report drafted by the new notified body and the new CE certificate should be sent to the ANSM as soon as possible.
- Other scenarios (in particular, where the end of the validity period date is not later than that of the NB denotification) will be examined on a case-by-case basis, especially where the device concerned is essential or has no existing alternative.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, November 2017 Issue (Thomson Reuters).