We recently published this Advisory for our US clients, but thought it may be a useful reminder for UK and EU teams given the number of updates in this area.

We are sure that you are aware that the European Union (EU) medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the beginning, as both the industry and the EU institutions, national authorities, and notified bodies have found it difficult to adapt to the stricter and demanding new legal requirements. There are ongoing delays in companies obtaining CE marks under the new regime, criticism that the rules are stifling innovation, and concerns about the impact on patients.

Given the calls for change, criticism, and ongoing consultations, this Advisory sets out the current status of developments and what is important to know when seeking to do business in the EU.

What You Need To Know

  • Devices on the EU market under the Medical Devices Directive can remain on the market under the transition periods. The validity of certificates have been extended and depend on various criteria and conditions being met. For medical devices, the deadline for such extensions is until December 31, 2027 or December 31, 2028 depending on the risk class. For IVDs, the deadline is until December 31, 2027, December 31, 2028, or December 31, 2029, again depending on the risk class. The Annex to the Advisory provides an overview of the relevant timelines and conditions that must be met.
  • There continues to be criticism and calls for change. The European Parliament called on the European Commission to amend the legislation and processes, and the European Commission is currently conducting a consultation with the aim of presenting a package of changes later this year. Feedback can be provided by anyone in the industry by March 21, 2025 using this online portal.
  • The EU institutions are continuing with implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR), with a number of pilot schemes and and new guidance, and a particular focus on expert groups to provide harmonized guidance. However, questions still remain about how the framework should operate and companies are facing inconsistent decisions about their products.

Top Tips for Companies

The implementation of the MDR and IVDR is progressing, but it is recognized that the identified challenges pose significant threats to the proper functioning of the regulatory framework, which is having an impact on the availability of medical devices and IVDs in the EU. The next couple of years will likely bring more revisions and adaptations to the current regulatory framework. In the meantime, companies should:

  • Be clear about which rules apply to your device and when.
  • Make sure you have a clear understanding of the transition provisions and the conditions attached, and can demonstrate these are met for your products.
  • Monitor developments and actions taken by the EU institutions.
  • Engage with consultations and pilot schemes to help shape the future legislation.
  • Establish a good relationship with your notified body and ensure you seek clarity on assessment timelines.
  • Enter into dialogue with your notified body if you see inconsistent or unclear decisions; remember that notified bodies are working within the same inconsistent framework that you are.