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Updates on the EU MDR transition period extension

Published by Isabella Greenock, Medical Device Paralegal on

Since December 2022, European regulatory bodies have been working to enact Regulation 2023/607 to extend the deadline for legacy medical devices transitioning over to the new MDR. The transition period had previously been set to end in May 2024. However, due to concerns of an imminent shortage of life saving medical devices, this deadline was extended to allow legacy devices CE marked under the old EU Directives to continue to be placed on the EU market until 2027 (for Class III and Class IIb implantable devices) or 2028 (Class IIb non-implantables, Class IIa and Class Im, Is and Ir devices).

As we previously reported, the regulation received Parliamentary approval back in February and was officially published on 20 March 2023. Over the past few weeks, there have been a number of new developments responding to the enactment of the regulation which we discuss below.

EU publishes guidance on the extension

To help manufacturers understand and make good use of the additional time provided by the extension, the European Commission recently published a Q&A on the practical aspects of the implementation of Regulation 2023/607.

The guidance document clarifies that only legacy devices (meaning devices which were CE marked on the basis of a notified body assessment prior to May 2021) can benefit from the extended transition period. In addition, it states that devices must meet the following conditions set out in Article 120(3c) of the MDR:

  1. the device must continue with the medical device directives
  2. there must be no significant changes to the design and intended purpose
  3. the device must not present an unacceptable risk to health and safety
  4. the manufacturer must put in place an MDR compliant quality management system by May 2024
  5. the manufacturer must lodge an application with a notified body for conformity assessment under the MDR by May 2024 and must sign a written agreement with the notified body by September 2024.

On point (5), the guidance states that manufacturers do not need to include all the documentation which would usually be required when applying to a notified body for conformity assessment under the MDR. In particular, manufacturers may exclude technical documentation for their device. However, the application must still include sufficient information to allow the notified body to verify the qualification of the product as a medical device, the classification of the device and the manufacturer’s chosen conformity assessment procedure. The written agreement reached with the notified body should then specify a plan for the submission of the technical documentation going forward.

UK regulator to accept extended CE certificates

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced its intention to continue accepting extended CE certificates as valid for devices placed on the market in Great Britain. Under current arrangements, extended CE certificates may continue to be recognised in Great Britain until July 2027. After this date, manufacturers will have to obtain UKCA certification under the new UK medical device regulations (which are yet to be published) if they wish to continue selling their device in Great Britain. 

The MHRA has also confirmed that the EU rules on extending CE certificates will apply automatically to medical devices placed on the market in Northern Ireland. This is under terms of the Northern Ireland Protocol which states that the EU medical device regulations should continue to apply in Northern Ireland post-Brexit.

To find out more about the regulatory requirements for medical devices in the EU, Great Britain and Northern Ireland, please register your interest in Regtik below. Regtik, our healthcare regulatory explorer tool, can help you navigate the legal maze by walking your product through a series of simple questions designed to determine which rules and regulations are applicable.  It is able to provide results for various jurisdictions (the US, EU, UK and Australia) in one single assessment and can be used multiple times on different versions of your product.