Skip to content

EU MDR Transitional Periods to be Extended

Published by Alec Denniff, Medical Device Paralegal on

The European Commission has proposed to extend the transitional periods of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), delaying their full implementation to at least 2027.

Background

The proposed amendments will come as a relief to those worried that challenges associated with implementing the new regulations could impact the supply of devices in Europe. In particular, Member States, the European Parliament and industry stakeholders have expressed concerns that these challenges could limit access to innovative medical devices. The Employment, Social Policy, Health and Consumer Affairs Council configuration (EPSCO) has also raised this issue, pointing to the insufficient capacity of notified bodies to certify medical devices in accordance with the MDR transitional periods (currently set to end on 26 May 2024). 

Since June of this year, EPSCO has been working with the Medical Devices Coordination Group (MDCG) to monitor notified body capacity. Their research shows that the number of notified bodies for medical devices  has increased from 30 in June, to 36 as of December. Furthermore, 26 applications for designation are currently in process, with three at an advanced stage. In relation to in vitro diagnostic devices, eight notified bodies are currently designated, one more than in June. Ten applications for designation are also in progress, with two at an advanced stage. In addition, the MDCG has adopted a list of 19 non-legislative mitigating actions, aimed at increasing notified body capacity and boost preparedness among manufacturers. 

It is clear that progress is being made on this front. Nevertheless, concerns continue to be raised that these actions will not be sufficient and that there is need for a targeted legislative amendment giving notified bodies and manufacturers more time to transition to the new regulations.

Proposed Amendments

In light of these concerns, the Commission was required to report to EPSCO on 9th December to present proposals for any additional solutions they deem necessary. In a press release published by the Commission, it was noted that around 23,000 devices certified under the old system have not yet transitioned to the new MDR. Certification for these devices is expected to expire by 26 May 2024 at the latest, meaning there is an imminent risk of shortages of life-saving medical devices. Therefore, the Commission has proposed additional measures.

In essence, the proposed legislative plans are to extend the transition period for the MDR to mitigate short-term risks. The exact details are not yet available. However, it is believed that the following changes will be made:

1. The transitional period will be extended, with staggered deadlines depending on device classification. MDD certificates will continue to be recognised until 2027 for Class IIb and Class III devices, and until 2028 for Class IIa and Class I devices requiring the involvement of a notified body.

2. Conditions will be implemented to ensure that the extension applies only to devices:
  • that do not present any unacceptable risks to health and safety
  • have not undergone significant changes in design or intended purpose, and
  • for which manufacturers have already undertaken steps to launch the certification process under the MDR (e.g. adapting their QMS system or submitting an application for conformity assessment).
3. The removal of the sell-off provision in Article 120(4) MDR and Article 110(4) IVDR.

 

It is expected that the full legislative proposal will be presented in January 2023. The MDCG is also due to release guidance on bridging the gap for expiring MDD certificates. The Commission will undertake a further review of the MDR by May 2027. If evidence demonstrates that the rules do not achieve their objective or have a negative impact on public health, patient safety or medical innovation, they will consider proposing additional amendments. 

UK MHRA: Lessons Learned from EU Experience?

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) could learn a lesson or two from the EU’s experience with implementing new medical device regulations. The UK government's response to the 2021 Consultation on the Future Regulation of Medical Devices addressed transitional arrangements for the UK’s new regulations. In particular, the government notes that transitional arrangements will be introduced for general medical devices and IVDs that hold a valid CE or ‘old’ UKCA certification.

These arrangements would allow, at a minimum, products to be placed on the market until either the certificate expires or for three years after the new regulations take effect (for general medical devices) or five years (for IVDs), whichever is sooner. The UK government also notes that conditions will apply to these arrangements, similar to those outlined above for the new EU extensions. It remains to be seen whether these transitional periods will be sufficient to ensure availability of medical devices for the UK market, or whether the UK will follow the EU’s experience in implementing new medical device regulations.