Does a recall of your medical device outside the EU have to be reported in the EU?

The myth: a field safety corrective action in another country is not an EU matter

It is commonly assumed that a recall or other corrective action carried out outside the EU concerns only the authorities of that country. Under the MDR, this assumption does not hold. Article 87(1)(b) requires manufacturers to report any field safety corrective action (FSCA) in respect of devices made available on the Union market, “including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.”

The reality: the reason for the action decides, not where it takes place

An FSCA undertaken in a third country is reportable in the EU where the device is also legally made available on the Union market and the reason for the action is not limited to the device made available in the third country.

The Medical Device Coordination Group (MDCG) illustrates this in its guidance MDCG 2023-3 (Rev.2, January 2025). A recall takes place in a third country because of a malfunction in certain lots. If the lots affected by the recall have also been made available on the Union market, all relevant competent authorities must be notified of the FSCA.

For this purpose, the Union market comprises the EU Member States and, through the European Economic Area, Norway, Liechtenstein and Iceland, as well as Türkiye via the Customs Union Agreement.

What counts as a field safety corrective action

According to MDCG 2023-3, an FSCA is a corrective action taken by a manufacturer for technical or medical reasons to either prevent or reduce the risk of a serious incident associated with a device made available on the market. A recall is only one example. The guidance lists, among others (non-exhaustive):

• the return of a device to the manufacturer or supplier, or a recall

• a device exchange, modification or destruction, and a retrofit by the purchaser of the manufacturer’s modification or design change

• advice from the manufacturer on the use of the device, such as additional maintenance information, increased calibration frequency, cleaning instructions or training

• changes to software or firmware related to a safety issue

• corrections to labelling and changes to packaging design that correct safety-related issues

Removals from the market for purely commercial, non-safety-related reasons are not included.

The exception

The exception is limited to an FSCA whose reason is confined to the device made available in the third country. Where the reason is not limited to that device, and the device is also legally made available on the Union market, the relevant competent authorities must be notified.

Who should be notified, and when

Timing: except in cases of urgency in which the manufacturer needs to act immediately, the FSCA must be reported without undue delay and in advance of the action being undertaken (Article 87(8)).

Channel: reports are submitted through the electronic system referred to in Article 92 (Article 87(1)).

Authorities: the system automatically transmits the report to the competent authorities of the Member States where the FSCA is being or is to be undertaken, and of the Member State where the manufacturer has its registered place of business (Article 92(7)). MDCG 2023-3 adds that the competent authority of the Member State where the manufacturer or its authorised representative has its registered place of business must always be informed, even if the FSCA is not undertaken there.

Notified body: the report is also transmitted to the notified body that issued the certificate for the device (Article 92(9)).

Users: the FSCA must be communicated without undue delay to the users or customers of the device through a field safety notice (MDCG 2023-3).