Are EU MDR obligations triggered if an EU manufacturer sells via a distributor outside the EU?

Question

Does the EU MDR place any obligations on an EU-based manufacturer if a product is sold outside the EU through a distributor? For example, if our company manufactures a device in the EU and sells it in a non-EU country via a local distributor, are there any ongoing compliance or reporting requirements under the MDR that the manufacturer must fulfill?

Dr. Oliver Eidel · Accepted Answer

The MDR only applies to devices that are placed on the market, made available, or put into service within the EU. So, if you sell your product outside the EU, the MDR itself doesn't impose obligations for those markets. The legal requirements of the destination country apply instead. However, if you sell the same device both inside and outside the EU, you should include post-market data (like complaints or incidents) from outside the EU in your PMS reports and PSURs. Significant incidents in other countries could still trigger field safety actions or CAPA in the EU if they reveal risks relevant to EU users.

Answer

There are some vigilance requirements under MDR Article 87.1.b. Field Safety Corrective Actions (FSCAs) in third countries related to a device on the EU market also need to be reported.

Are EU MDR obligations triggered if an EU manufacturer sells via a distributor outside the EU?

2 Answers

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