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MDCG issues new guidance for importers and distributors under MDR/IVDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

MDCG 2021-23 is a new guidance document published by the Medical Device Coordination Group (MDCG) addressed to importers and distributors of medical devices on the requirements in Article 16 of the regulations.

Article 16 is headed ‘Cases in which obligations of manufacturers apply to importers, distributors or other persons’, and apply in cases such as:

  • Making a device available under its own name/brand;
  • Changing the intended purpose of a device;
  • Modifying a device such that compliance is affected. This may include:
    • Addition to and/or translation of information supplied by the manufacturer;
    • Changes to the outer packaging.

Article 16(4) of the MDR / IVDR provides for a notified body (NB) to certify that the quality management system (QMS) of the distributor or importer complies with the requirements laid down in Article 16(3).

The guidance explains that it is mainly focused on activities performed by NBs, providing also clarification on the QMS they are expected to assess.

A separate MDCG guidance document, in the form of Questions & Answers, is apparently being developed to complement MDCG 2021-23 and address implementation of other relevant requirements for distributors and importers introduced by MDR/IVDR Article 16.