The importer is defined by Article 2(33) of the MDR as any natural or legal person established within the European Union that places a device from a third country on the Union market. Article 13 of the MDR imposes obligations on the importer that go well beyond simply moving goods.
The mandatory checks before any placing on the market
Before placing a device on the European market, the importer must carry out several checks.
It must ensure that the non-EU manufacturer has designated an EC REP authorised representative in accordance with Article 11. The importer cannot stand in for the EC REP, but it is required to verify that this designation exists.
It must verify that the device bears CE marking, that the EU declaration of conformity has been drawn up, and that the labelling and the IFU comply with MDR requirements in the language of the Member States where the device is marketed.
It must verify that the device is registered in EUDAMED in accordance with the applicable requirements.
If the importer has reason to believe that the device does not comply with MDR requirements — incomplete labelling, absence of CE marking, absence of an EC REP — it must not place it on the market. It must inform the manufacturer and its EC REP and, where the situation presents a safety risk, the national competent authority.
The traceability obligations
The importer must register its details in EUDAMED and keep the information needed to identify the manufacturers, the devices and the lots placed on the market for at least 5 years (10 years for implantable devices). This record must enable the competent authorities to trace back up the distribution chain in the event of an incident.
The vigilance obligations
An importer that receives a complaint or an incident report concerning a device it has placed on the market must immediately forward this information to the manufacturer and its EC REP. It is a link in the transmission chain — it cannot stand in for the manufacturer with regard to reporting obligations, but neither can it ignore or filter the information it receives.
What this means organisationally
An importer that markets non-EU medical devices must have put in place an internal process for verifying conformity before any placing on the market, a system for tracing imported lots, and a procedure for forwarding complaints. These processes must be documented — they will be checked during a market surveillance inspection.
Regulatory source: Article 13 of Regulation (EU) 2017/745 — EUR-Lex