After a delayed start, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the “Medical Devices Regulations”) have applied for some time now, with certain rolling transition periods still in play.

In early 2024, the European Commission proposed Regulation (EU) 2024/1860 (the “Amending Regulation”) amending aspects of both Medical Devices Regulations –this Amending Regulation entered into force in July 2024. It is the latest piece of legislation which amends the Medical Devices Regulations.

Interruption or discontinuation of supply

The Amending Regulation imposes obligations on manufacturers to inform the relevant competent authority and health institutions about interruption or discontinuation of supply of certain devices. This obligation applies from 10 January 2025. A Q&A was issued in October 2024 and updated in December 2024.

Some key points to note:

• The obligation to inform about an anticipated interruption or discontinuation of supply is with the manufacturer only (whether established inside or outside the European Union). Legal responsibility for this task cannot be delegated, but the assistance of the manufacturer’s authorised representative, other economic operators or a third party, can be engaged in terms of practical implementation.

• The manufacturer must determine whether it is reasonably foreseeable that an interruption or discontinuation of their device could result in serious harm of or risk of serious harm to patients or public health in one or more Member States.

• Who to notify? The manufacturer should inform the economic operators, health institutions and healthcare professionals to whom the manufacturer directly supplies the device, as well as the competent authority of the Member State where it or its authorised representative is established. It is important to note that responsibility for onward information sharing in the downstream supply chain lies with the relevant economic operators.

• When to notify? The information should be provided at least six months before the anticipated interruption of discontinuation.

• Exceptional circumstances are provided for, where it is not possible to anticipate an interruption of  supply i.e. due to sudden and unexpected external or internal circumstances. In this case, the notification should occur without undue delay.
• The European Commission’s Medical Device Co-Ordination Group has recently published a “Manufacturer Information Form” plus annex, to be completed in the event of notification being required to a competent authority.

The Medical Devices Regulations are a complex framework which continues to evolve. To this end, in December 2024, the European Commission opened a public consultation with a view to a targeted evaluation of the rules. The legislation provided for an evaluation to be conducted by May 2027, but in light of the “significant challenges encountered in transitioning to the new rules” as cited in the Commission’s evaluation document, it was decided to launch this in 2024. This consultation will close on 31 March 2025.

For more information please contact our Life Sciences Group.