Importer as the Entity Responsible for Device Registration or Notification

In many jurisdictions the importer must submit the device notification or registration on its own.
Example: in Poland the importer must notify the URPL within seven days of the product’s first placement on the market.
Elsewhere the obligation is handled through local regulators’ e-portals or requires prior licences (e.g. AFE in Brazil).

Within the EU the importer does not register the device in EUDAMED independently, but must be listed as an “economic operator” in the supply chain. In practice this means the manufacturer or authorised representative must register the importer and link it to each device. Only then does the importer gain access to the data and the ability to monitor compliance.

Data Importers Must Provide During the Registration Process

To participate properly in a registration, the importer must supply:

  • full identification details (company name, address, tax number—NIP, CNPJ, etc.),
  • a document confirming consent to act as the importing entity,
  • a contract that defines the scope of responsibility with the manufacturer,
  • evidence of regulatory authorisations (e.g. AFE, MDEL),
  • an SRN in the EU (where applicable),
  • contact details for the person responsible for compliance and distribution.

In some systems (such as ANVISA) the importer is also responsible for updating registration data and communicating with the authority. Under the EU MDR/IVDR its role focuses on verifying device compliance before placing it on the market and co-operating with market-surveillance authorities.

When Must the Importer Register the Device?

Depending on the market, the importer may actively file the registration or simply be referenced in the dossier.
United Kingdom: the importer does not register, but a non-UK manufacturer must appoint a UKRP, which submits the notification.
Brazil: the importer files the application with ANVISA and becomes the legal holder of the registration.
Canada: where the manufacturer has no local presence, the importer can obtain an MDEL and is responsible for GDP-compliant distribution.
In many third-country markets the importer is usually the representative and applicant, so controlling that relationship is critical. The importer’s obligations vary by territory—see USA registration, Canada registration, LATAM registration  or UK registration for different engagement levels and liabilities.

The Importer and the EUDAMED System

In EUDAMED the importer must be registered as an actor and receive an SRN—but only after being linked to a device by the manufacturer or EC-REP. The importer cannot self-register, yet its data are mandatory for full supply-chain traceability. Failure to assign an importer to a device results in an incomplete registration and potential MDR/IVDR breaches.

The importer must also check label, packaging and IFU compliance—including language versions. If non-conformities are detected, it must immediately inform the manufacturer and the competent authority.

How Pure Clinical Supports Importers in the Registration Process

We guide importers in aligning their role with the regulatory requirements of every market they serve. Our support covers documentation, formal filings and operational compliance—whether the importer is simply listed in EUDAMED or is the active registrant with ANVISA, URPL or MHRA.

Pure Clinical provides:

  • preparation of all documents required for notification or assignment to a device,
  • analysis of importer obligations within the specific legal framework,
  • obtaining the SRN and actor registration in EUDAMED,
  • communication with the manufacturer and EC-REP,
  • label and IFU compliance review,
  • audit or inspection readiness support,
  • pre-registration audits and gap assessments.

The importer can no longer act as a passive receiver of goods. Under the MDR, IVDR and various national systems it is an active compliance stakeholder—and its mistakes can block registrations or trigger product withdrawals from the market.

FAQ

Does a medical device importer have to register itself in EUDAMED?

No. An importer cannot register itself in EUDAMED as an actor - it must first be assigned that role by the manufacturer or the Authorised Representative (EC-REP). Only after this assignment can the importer obtain its own SRN (Single Registration Number).

What is an SRN and who assigns it to the importer?

An SRN (Single Registration Number) is a unique actor identification number within the EUDAMED system. The importer receives it only after being assigned by the manufacturer or the EC-REP - it cannot generate one or register on its own initiative.

Since when has actor registration in EUDAMED been mandatory?

Actor registration (including importers) in EUDAMED's Actor Registration module became mandatory on 28 May 2026. Failing to assign an importer to a device results in an incomplete registration and a risk of non-compliance with the MDR/IVDR.

What data must an importer provide during device registration?

The importer must provide full identification details (name, address, tax ID or its local equivalent), a document confirming its agreement to act as the importer, documentation defining the scope of its responsibility (such as an agreement with the manufacturer), confirmation of its regulatory authorisations, and the contact details of the person responsible for compliance.

What deadline applies to an importer notifying a device in Poland?

In Poland, the importer must notify the URPL (Office for Registration of Medicinal Products) within 7 days of the device's first placement on the domestic market.

Are an importer’s obligations the same in every country?

No. The importer's role varies by market — in the United Kingdom, the importer does not carry out the registration itself (this is done by the UKRP), in Brazil the importer submits the application to ANVISA and acts as the registration holder, and in Canada it may apply for an MDEL licence if the manufacturer has no local presence.

What role does an importer play in Brazil when registering medical devices?

In Brazil, it is the importer who submits the application to ANVISA and acts as the holder of the device registration - unlike in the EU, where this role is held by the manufacturer or its Authorised Representative.

What is an importer responsible for after a device is placed on the EU market?

The importer must monitor the compliance of the labelling, packaging and instructions for use (IFU), including the accuracy of language versions, and must immediately notify the manufacturer and the relevant supervisory authorities if any non-conformity is found.

Can an importer be held liable for a device’s non-conformity?

Yes. Importer errors - such as failing to verify documentation, keeping outdated registration data, or non-compliant labelling - can block a device's registration or lead to its withdrawal from the market, since the importer is an active participant in the compliance chain, not merely a passive recipient of the device.

How does Pure Clinical support importers with the registration process?

Pure Clinical prepares the documents needed to notify or assign the importer to a device, analyses its obligations under the specific legal system, helps obtain an SRN and register in EUDAMED, coordinates communication with the manufacturer and the EC-REP, and assesses the compliance of labelling and IFU.