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Focus on Regulation

The HPRA published a MDR/IVDR Guide for Distributors of Medical Devices

The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations that must be met by distributors in relation to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

Although the MDR and the IVDR are not applicable before respectively 26 May 2020 and 26 May 2022, it is important that all economic operators, including distributors, start preparing for their new related obligations as soon as possible.

The Guide addresses and clarifies the obligations which will be applicable to distributors of medical devices under the MDR and the IVDR. The document also includes some important recommendations concerning the methods that can be used by distributors to comply with their obligations and ensure good distribution practices.

As an illustration, the Guide recommends that distributors of medical devices establish a quality management system. According to the HPRA, this quality management system provides assurance that only medical devices which comply with the MDR and IVDR are distributed in the EU, that noncompliant, defective or unsuitable medical devices can be detected, that traceability is maintained and that non-conformances and the introduction of changes are controlled. The Guide makes reference to the EN ISO 13485 standard which could be used to establish this quality management system.

The Guide also recommends that each distribution centre appoint a person with appropriate training and experience who has primary responsibility for ensuring that regulatory responsibilities are met and that the quality management system is effective. This person could also serve as the primary contact between the competent authorities and the distributors.

The Guide is divided into 14 chapters, including:

  • legislative basis;
  • implementation of a quality system;
  • personnel and staff training;
  • documentation and record keeping;
  • medical device receipt, storage and supply;
  • management of returned medical devices;
  • falsified medical devices;
  • medical device recalls;
  • outsourced activities;
  • transportation; and
  • internal audits.