Medical Devices Coordination Group

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The day is finally here! Four years after it entered into force, the Medical Devices Regulation (MDR) is applicable today, the 26 May 2021. We have discussed the aspirations and implications of the MDR, we have commented on the slow rate of implementation, and we have heard, and share, some of the frustration expressed by companies as they have prepared for today. From today, industry, regulatory bodies, external advisors and customers will be able to experience the consequences of the radical reform of the medical devices regulatory framework that has been introduced by the MDR.

We have published several blog posts on the key changes and progress of the implementation of the MDR. In this post, now the MDR is officially applicable, we briefly cover where we stand in relation to some of the issues and concerns for the industry. The European Commission recently said that “the 26th of May is not an end date” and we couldn’t agree more. While the MDR was focused on increasing patient safety and the oversight of devices, there is still a lot of work to be done, and there remains a number of outstanding questions. We believe there will need to be a great deal of flexibility by all parties over the coming months in other to avoid disruption for patients.…

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Last week, the Medical Device Coordination Group (MDCG) published two new guidance documents under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). These concern the “person responsible for regulatory compliance” and the “implant card” required under the new Medical Devices Regulations (MDR).

These are the latest of the guidance published by the MDCG and collated on the European Commission’s website before the Regulations come into force in May 2020 (for medical devices) and May 2022 (for in vitro diagnostic medical devices).

Persons Responsible for Regulatory Compliance

Under Article 15 of the MDR and Article 15 of the IVDR, “Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.” While the Regulations set out requirements on the qualification of the PRRC and an overview of their responsibilities, the guidance adds additional detail to these requirements, and clarifies the PRRC requirements for manufacturers and authorised representatives (AR), notably that:…

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