Question 1

What is an Importer under MDR/IVDR?

Accepted Answer

Under MDR Article 2(33) and IVDR Article 2(26), an Importer is any natural or legal person established in the EU who places a device from a third country on the EU market. The Importer has specific legal obligations regarding verification, documentation, and traceability.

Question 2

Do we need an Importer if our company is outside the EU?

Accepted Answer

Yes. If the manufacturer is not established in the EU, a device can only be placed on the EU market if there is an Importer established in the EU. The Importer is the economic operator who first makes the device available on the EU market.

Question 3

What is the difference between an Importer and an Authorised Representative (EC-REP)?

Accepted Answer

The EC-REP acts on behalf of the manufacturer for regulatory tasks (competent authority liason, vigilance). The Importer is responsible for verifying that the device is compliant before placing it on the market and for maintaining traceability. Both roles are required for non-EU manufacturers, and they can be the same or different entities.

Question 4

Can our distributor act as the Importer?

Accepted Answer

Legally, yes - a distributor can also be the Importer if they are the first to place the device on the EU market. However, combining these roles can create conflicts of interest. An independent Importer provides impartial verification without commercial pressure to overlook compliance issues.

Question 5

What are the Importer's obligations under MDR Article 13?

Accepted Answer

The Importer must: verify that the device has a CE marking and DoC, verify that the manufacturer and EC-REP are identified, verify that the device is labelled correctly including UDI, keep a register of complaints and non-conforming devices, cooperate with competent authorities, and forward information about suspected incidents to the manufacturer and to its EC-REP

Question 6

Does the Importer need to be registered in EUDAMED?

Accepted Answer

Yes. Importers must register in EUDAMED as economic operators. This registration is mandatory and must be completed before placing devices on the EU market.

Question 7

How long must the Importer keep records?

Accepted Answer

The Importer must keep documentation (DoC, Certificate if applicable) available for competent authorities for at least 10-15 years after the last device has been placed on the market. They must also maintain a register of complaints, non-conforming devices, and recalls.

Question 8

Can MedNet EC-REP act as both EC-REP and Importer?

Accepted Answer

Yes. MedNet EC-REP can serve as both your Authorised Representative and your Importer. This provides a single point of contact for regulatory compliance while maintaining the independence required for proper verification. However, we keep these functions operationally separate to ensure impartial compliance checks.

Question 9

Do Importer obligations apply to IVDs as well?

Accepted Answer

Yes. IVDR Article 13 contains equivalent Importer obligations for in vitro diagnostic medical devices. The requirements are essentially the same as under MDR.

Question 10

What about the UK? Do we need a UK Importer?

Accepted Answer

Yes. For devices placed on the Great Britain market (England, Scotland, Wales), a UK-based Importer is required if the manufacturer is not established in the UK.

Ensure Compliance with MedNet EC-REP as Your Regulatory Importer

Our Role as Importer

Verification of compliance

Registration controls

Traceability & vigilance

Regulatory importer explained

Frequently Asked Questions

Achieve compliant EU imports