Delay to the EU Medical Devices Regulation

Introduction

European Parliament has voted to postpone the application of the Medical Devices Regulation (MDR) by one year to May 26, 2021 in order to alleviate pressure on the medical device industry during the current coronavirus pandemic.

To take effect, the delay must be approved by Member States before May 26, 2020.

Background

The reforms bought in by the MDR seek to increase medical device safety and effectiveness.

Among the changes are:

• New rules to tighten the classification system and increase its scope to cover more devices;
• A requirement for notified bodies to consult the European Commission on the adequacy of its clinical evaluations and post market clinical follow up plans before granting certificates; and
• The introduction of Unique Device Identification (UDI) and the requirement to place this on labels in order to provide traceability on all medical devices.

Timetable for Implementation

Current increased demand for medical devices, on top of travel restrictions, isolation and social distancing measures, has placed a considerable burden on manufacturers and the medical device industry generally. The implementation of the new regulations would have caused device shortages and delays, placing even more pressure on the industry.

The delay will allow manufacturers to prioritise the provision of medical devices during the pandemic. It will also give manufacturers and others in the supply chain time to ensure they are ready for MDR instead of relying on the transitional period, the final day of which remains May 26, 2024.

How we can help

Technical files and clinical evaluation reports will still need to be updated and new quality management systems put into place. Revised rules and increased scope of the classification system will also require devices to be re-classified in a potentially costly process. Furthermore, since the final date of the transitional period has not also been postponed, manufacturers may still struggle to make full preparations for the new regulations by the 2024 deadline.

Norton Rose Fulbright can provide advice and assistance on the implementation of new management systems and risk assessments, as well as compliance issues as and when they arise. It is also worth noting that the delay falls after the end of the Brexit transition period and it remains unclear if the delay will affect the UK’s implementation of the new regulations. Norton Rose Fulbright will be well placed to advise on developments as negotiations between the UK and EU continue in the lead up to the deadline of December 31, 2020.