Where the manufacturer is not established in a Member State, the notice goes to the authority of the country where its authorised representative is established. The choice of representative therefore decides which authority receives it and in which language.
Supply obligations
Discontinuing a product line in Europe now takes six months of notice
Commercial decisions to withdraw a device from a market are usually taken on a quarterly cycle and communicated when the last order ships. Article 10a MDR, added by the 2024 amendment, puts a regulatory notice period in front of that decision, and almost no file arriving from outside the Union has a process for it.
The obligation in the words of the Regulation
Article 10a(1) MDR:
Where a manufacturer anticipates an interruption or a discontinuation of the supply of a device, other than a custom-made device, and 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, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation.
The second subparagraph sets the timing: other than in exceptional circumstances, the information is provided at least six months before the anticipated interruption or discontinuation, and the manufacturer states the reasons to the competent authority. The authority then informs the other Member States and the Commission, and each operator in the chain passes the information down to whoever it supplies directly.
What this changes in practice for a manufacturer outside the Union
The duty attaches to an anticipated interruption where serious harm is reasonably foreseeable. Somebody has to make and record that assessment, which means commercial planning has to reach the regulatory function before the decision is final.
A component that goes end of life, a contract sterilizer that changes its schedule or a plant transfer can all create an interruption long before anyone calls it a discontinuation.
Distributors and importers who receive the notice must pass it on without undue delay, so a late notice from the manufacturer becomes a compliance problem for its European customers as well.
Where this usually breaks
In portfolios we review, the gap is not unwillingness. It is that nothing in the quality system connects a discontinuation decision to a regulatory notice. The procedure that governs product withdrawal talks about stock, service parts and customer communication, and stops there.
The fix is small compared with most MDR work. One trigger in the change control procedure, one assessment record, one notification template and a defined route to the representative. It is worth doing before an authority asks why a device that disappeared from a hospital catalogue was never notified.
Questions about withdrawal and supply
We are replacing a device with a newer model. Is that a discontinuation?
It can be, if supply of the existing device stops and the transition could leave users without an equivalent option. The assessment turns on foreseeable serious harm, not on the commercial framing.
Does this apply to a temporary shortage?
Article 10a covers interruption as well as discontinuation. A temporary interruption that could foreseeably cause serious harm is in scope.
What if we did not have six months of warning ourselves?
The Regulation allows for exceptional circumstances. The reasons have to be stated to the competent authority, so the record of when the manufacturer knew becomes important.
Can our authorised representative send the notice for us?
The representative is the natural route to the authority and can prepare and transmit it under the mandate. The underlying obligation, and the assessment behind it, stay with the manufacturer.
Official basis checked on 15 August 2026
The MDR provisions cited on this page were checked against the official EUR-Lex text.
Regulation (EU) 2017/745 (MDR) in EUR-Lex →
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