New EU guidance clarifies the new notification obligation in case of interruption or discontinuation of supply of medical devices
In case of interruption or discontinuation of the supply of medical devices, the new Article 10a contains a notification obligation. The information obligation applies to the manufacturer who is to inform (i) all downstream economic operators, (ii) health institutions and (iii) healthcare professionals to whom it directly supplies the device as well as (iv) the competent authority of the Member State where it or its authorised representative is established.
This obligation to inform only arises where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States.
It is reminded that the new Article 10a of Regulation (EU) 2017/745 on medical devices ("MDR") and Regulation (EU) 2017/746 on in vitro medical devices ("IVDR") will apply from 10 January 2025, as defined in Article 3 of Regulation (EU)2024/1860 on the obligation to inform in case of interruption or discontinuation of supply etc.
The European Commission recently published a Q&A concerning the practical aspects of the new information duty being implemented in both the MDR and IVDR.
In the Q&A, the European Commission clarifies, among other things, when the notification obligation applies, what types of devices it covers, who is to be informed, and when the notification is to take place.
See the Q&A from the European Commission for further details or reach out to Plesner's Life Science team in case of questions.