Operational Obligations of Medical Device Importers

An importer is an economic operator based in the EU who places a medical device or IVD originating outside the EEA on the market for the first time. According to Article 13 of MDR and IVDR, the importer is responsible for verifying the formal and technical compliance of each device before making it available in the EU:

  • CE marking must align with the certification scope and UDI code.
  • The EU Declaration of Conformity and technical documentation must be available, complete, and up to date.
  • A manufacturer from outside the EU must have an appointed authorized representative.
  • The importer must place their contact information (name and address) on the product, label, or instructions in a permanent and legible manner.
  • The importer is responsible for ensuring transportation and storage conditions comply with the manufacturer’s specifications (e.g., temperature, humidity).

These obligations must be documented in internal quality system procedures and align with Good Distribution Practice (GDP).

Registration in EUDAMED and SRN Number

Each importer must register as an economic operator in EUDAMED, obtain a Single Registration Number (SRN), and link it to the products they place on the market. The SRN:

  • Is required for incident and FSCA reporting,
  • Must be linked to PMS reports and UDI data,
  • Is essential for communication with URPL and notified bodies.

Lack of SRN prevents full product traceability and recognition of the importer as a legal participant in the EU market.

Incident Reporting and Cooperation with the Manufacturer

The importer actively participates in the Vigilance and PMS systems. Their responsibilities include:

  • Monitoring user reports and complaints and forwarding them to the manufacturer,
  • Reporting serious incidents to the manufacturer and their representative,
  • Collaborating in FSCA, PMS, and market trend analysis,
  • Ensuring availability of information required by the notified body or URPL.

Importers should have a procedure for responding to market feedback and reporting forms aligned with MDCG 2023-3.

Documentation Obligations and Archiving

Importers must retain documentation confirming product compliance for at least 10 years after the last product release to market (15 years for implantable devices). Documentation includes:

  • Copies of the EU Declaration of Conformity,
  • Manufacturer and EU representative data,
  • UDI identifiers and SRN data,
  • Complaint, non-compliance, FSCA, and market withdrawal records,
  • Documentation of surveillance actions and communication with the notified body.

Language Compliance and Instruction Verification

Importers are responsible for ensuring that instructions for use and product labeling are available in the official language of the Member State where the device is marketed. In Poland, this must be Polish. Lack of language compliance may lead to denial of market access or product withdrawal by URPL.

Importer’s Role in Product Change Oversight

Importers must monitor changes in technical specifications, certification, and intended use. In the case of a significant change by the manufacturer, importers should:

  • Obtain a new Declaration of Conformity and verify its consistency with the certificate,
  • Update documentation kept for surveillance purposes,
  • Ensure UDI-DI data has not been changed without legal basis.

Common Errors Made by Importers

The most frequently identified non-compliances include:

  • Missing importer identification on labels or instructions,
  • Incomplete verification of documentation provided by the manufacturer,
  • Lack of an integrated complaint management system,
  • Failure to forward incident and complaint reports,
  • Failure to register an SRN and link data to EUDAMED.

Consequences include administrative penalties up to PLN 5,000,000, loss of trading rights, and rejection of compliance by the notified body.

How Pure Clinical Supports Importers in MDR and IVDR Compliance

The Pure Clinical team offers comprehensive support for operational and formal compliance of importers:

  • Verification of labeling, instructions, and technical documentation,
  • Registration in EUDAMED and SRN acquisition,
  • Implementation of complaint and incident reporting procedures per MDCG,
  • Development of document archiving systems and change oversight protocols,
  • Training for quality and compliance teams handling imported products,
  • Audit preparation for URPL and notified bodies.

FAQ

Can an importer rely on the technical documentation stored by the manufacturer?

No. The importer must have direct access to the current EU Declaration of Conformity, UDI documentation, and SRN data. Failure to maintain these documents at the importer’s premises or within the QMS is considered a violation of MDR/IVDR requirements, regardless of the commercial relationship with the manufacturer.

Does a change of importer by the manufacturer require an update in EUDAMED?

Yes. A change of importer constitutes a change in the economic operator within the distribution chain and must be registered in the EUDAMED system, including assignment of a new SRN. Failure to notify such a change may result in the unlawful placing of devices on the EU market.

Can an importer distribute a device in multiple EU countries without updating language labelling?

No. Each EU Member State requires instructions for use and labelling to be provided in the official language(s) of the country of distribution. The importer must ensure that language versions are available and compliant with both MDR/IVDR and national regulations.

What IT tools support importers in fulfilling MDR/IVDR obligations?

MDR/IVDR-compliant importing is supported by eQMS platforms equipped with modules for: – archiving Declarations of Conformity and certificates, – monitoring UDI and SRN data, – recording complaints and incidents (e.g. Greenlight Guru, MasterControl), – integration with the EUDAMED database via XML formats or API interfaces.