The New European Medical Device (MDR) and In-Vitro Regulation (IVDR)

AUTHOR: Anna Cesar | Associate, Regulatory Compliance

The transition period for the new European Medical Device (MDR) and In-Vitro Regulation (IVDR) will end soon – May 26, 2021, and May 26, 2022, respectively. If you are an importer of medical devices or IVDs to the EU, you must be prepared for changes.

Importer role under MDR & IVDR

The roles and responsibilities of importers will significantly change under the new MDR & IVDR. Two key objectives of the new regulations are to expand the importers role with regard to device classification and traceability.

All economic operators including manufacturers, authorized representatives, importers, and distributors are expected to cooperate, thus the obligations for each were detailed in the new regulations.

The MDR & IVDR define importer as any natural or legal person established within the European Union that places a device from a third country on the Union market.

The general obligations of importers are detailed in article 13 of both MDR and IVDR. Chief among these is the responsibility to ensure that only MDR-compliant devices are placed on the EU market.

Importers must ensure their products meet the following criteria at the time of import:

  • Device is CE marked
  • Is accompanied by an EU Declaration of Conformity
  • Has appropriate MDR/IVDR label and Instruction for Use
  • The manufacturer is identified
  • UDI has been assigned by the manufacturer, where applicable
  • An EU authorized representative has been designated by the manufacturer
  • Verify if the device has been registered in EUDAMED
  • Indication of the importer (with name and address) given on the device, its packaging or in a document accompanying the device.

Additionally, importers are responsible for certain quality and safety activities which include:

  • In case the importer considers a device as non-conform to MDR, the device shall not be placed on the market.
  • Manufacturer and the authorized representative shall be informed about nonconformities by the importer.
  • In the event of serious risk or falsified device the competent authorities have to be informed by the importer.
  • EUDAMED registration of the importer (Article 31).
  • Verification of the device registration in EUDAMED by the importer (Article 29).
  • Control of storage or transport conditions so that they are in compliance with manufacturer’s requirements when the device is under the importer’s responsibility.
  • Keep a register of complaints.
  • Cooperate with the manufacturer, authorized representative, distributors, and competent authorities.
  • Inform manufacturer and its authorized representative about complaints.
  • Keep a copy of the EU declaration of conformity and relevant certificates, if applicable.

Frequent Asked Questions Addressed by the European Commission

When do the Regulations apply?

The Medical Devices Regulation (MDR) (2017/745/EU) will apply from May 26, 2020 and the In Vitro Medical Device Regulation (IVDR) (2017/746/EU) will apply from May 26, 2022 – the respective Dates of Application (DoAs).

Some provisions of these Regulations will apply earlier (e.g. regarding Notified Bodies and the Medical Device Coordination Group). Some will apply later (e.g. Unique Device Identification and labelling).

Do certificates issued by Notified Bodies under the existing Directives remain valid after the DoA?

Yes, certificates will generally remain valid until the end of the period indicated on the certificate, or until May 27, 2024, whichever is the earlier. After May 27, 2024, certificates issued under the Directives will become void.

For a complete list, see the list of FAQs from the Competent Authorities for Medical Devices at: https://www.camd-europe.eu/regulatory/available-now-mdrivdr-transitional-faqs/

For access to the complete publication, please visit the European Commission website at: https://ec.europa.eu/health/md_sector/overview_en 

Please send your questions to Marken at Tradecompliance@marken.com.

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