With effect from 10 January 2025, manufacturers are obliged, in accordance with Article 10a of Regulation (EU) 2017/745 or Regulation (EU) 2017/746, to notify interruptions or discontinuations of the supply of a medical device that is not a custom-made device (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401860).

The requirement for notification is that the interruption or discontinuation of supply may result in serious harm or a risk of serious harm to patients or public health in one or more Member States.

Notification of the probable interruption or discontinuation shall be made to the competent authority of the Member State in which he or his authorised representative is established and to the economic operators, health institutions and healthcare professionals to whom the manufacturer supplies the device directly.

In Germany, the notification must be sent to the Federal Institute for Drugs and Medical Devices (BfArM) (see Section 7a in conjunction with Section 85 (2) No. 4a of the Medical Devices Law Implementation Act - MPDG).

Section 7a MPDG requires electronic notification in machine-readable form. This requirement is fulfilled by using the notification form https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#article-10a--interruption-or-discontinuation-of-supply published by the European Commission. Here you will also find the current Q&A document relating to Article 10a.

Please send the notification, including the notification form, by e-mail to mp-art10a@bfarm.de .

Note: Interruption or discontinuation of the supply of a medical device that was expected by the manufacturer before 10 January 2025 does not have to be reported, even if the interruption or discontinuation itself occurs after 10 January 2025.