Life Sciences Horizons Brochure 2025 - Flipbook - Page 7
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2025 Horizons Life Sciences and Health Care
Notification duty for device supply interruptions in the EU
As of 10 January 2025, medical device and in vitro
diagnostic (IVDs) manufacturers are subject to a new
obligation under Article 10a of the Medical Device
Regulation (MDR)/IVD Regulation (IVDR) to inform
their competent authority, impacted economic
operators in their supply chain, health institutions
and health care professionals to whom they directly
supply devices/IVDs if they anticipate interruption
or discontinuation of the supply of certain medical
devices and IVDs.
This notification obligation, introduced by Regulation (EU)
2024/1860, aims to help competent authorities and health
institutions anticipate foreseeable disruptions in the supply
of medical devices and IVDs in the EU with a view to taking
measures to mitigate device and IVD shortages where necessary
to ensure patient health and safety.
This obligation rests solely with manufacturers, whether
established in or outside the EU. Economic operators informed by
a manufacturer of an anticipated interruption or discontinuation
must pass this information on to the downstream supply chain.
This requirement covers all models or types of devices (including
legacy devices) placed on the EU market, for which it is reasonably
foreseeable that a supply interruption or discontinuation could
result in serious harm or pose a risk of serious harm to patients
or public health in one or more EU Member States. Notifications
should be made six months prior to the anticipated interruption/
discontinuation unless exceptional circumstances prevent the
manufacturer from doing so (such as natural disasters, a sudden
inability to obtain raw materials or components, or economic or
financial reasons, etc.).
Manufacturers must assess if Article 10a of the MDR/IVDR is
applicable to their devices and document their conclusions.
Affected manufacturers should also update their Quality
Management System (QMS) procedures and existing agreements
with economic operators in the supply chain to ensure
compliance and avoid non-conformities during forthcoming
Notified Body audits/inspections.
The European Commission published a related Q&A, which
explains the conditions for the application of the notification
obligation, describes key concepts of this requirement, provides
an illustrative list of potential reasons for interruption or
discontinuation, and specifies parameters manufacturers must
consider when assessing this obligation to their products.
Competent authorities in several EU Member States, including
Belgium, France, Germany, the Netherlands, and Portugal, have
issued guidance detailing Article 10a notification requirements
in their respective jurisdictions.
Fabien Roy
Partner
Brussels
Anastasia Vernikou
Associate
Brussels
