The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU). Until the breakup becomes official, British legislation should remain fully aligned with European rules and CE marked products should be able to move freely across the Channel. The UK remains a member of the EU until the UK invokes Article 50 of the Lisbon Treaty, followed by a two year time-frame for negotiations regarding conditions of the exit and future relationships, with the possibility of an expanded time-frame of 5 or even 10 years. The UK’s National Standards Body, known as British Standards Institutions (BSI), released a statement stating:
For now, it’s business as usual and most importantly, we we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.
The UK has EU Medical Directives transposed into national law. So even as the UK leaves the EU, these laws will remain in place unless the UK government decides to change them. The timing of the exit could affect the UK implementation of the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), which address pre-market conformity with requirements, post-market oversight, and traceability of devices throughout the supply chain, among other things. The EU could potentially approve the MDR and IVDR by September 2016 with enforcement beginning in 2020.
At present, medical devices can be marketed throughout the European Economic Area (EEA) once they have a CE Mark issued by any Notified Body. A CE Mark indicates that the product meets the requirements of the applicable European Commission (EC) Directives. The future of UK based Notified Bodies is unclear, but in its statement, BSI expressed confidence that it will continue to be recognized as a Notified Body for Medical Devices after UK’s exit from the EU.
Another point of uncertainty involves Authorized Representatives, also known as EC Reps, which are legal representatives that provide access to the European market to non-EU manufacturers. The future of UK based Authorized Representatives is up in the air, but Sinead Keogh, Director of the Irish Medical Devices Association (IMDA) sees the possibility that UK based Authorized Representatives may not be eligible to represent manufacturers within the EU forcing companies to establish Authorized Representatives within another EU state.
Ronald Boumans of Emergo Group sees four options for the UK upon the UK’s exit from the EU:
- Become part of the EEA or European Free Trade Association (EFTA) similar to Norway, Iceland, and Liechtenstein. The free movement of goods will remain under the CE Marking of the applicable categories of products and Notified Bodies and Authorized Representatives can keep working from the UK.
- Set up a mutual recognition agreement (MRA) similar to ones the EU has with Australia, New Zealand, and Switzerland. Depending on the agreed upon conditions, this option may allow for Notified Bodies and Authorized Representatives to continue operating from within the UK.
- Set up a special agreement similar to the United States of America (USA). There would be certain rules that help manufacturers place medical devices on the other market.
- Trade under the general World Trade Organization (WTO) arrangement where market entry would require extra work and costs.
Hugh Davies, a pediatrician and Research Ethics Adviser at the UK’s Health Research Authority, however, warns:
If a deal cannot be done, device manufacturers would need to go through approval twice, once for the UK market and once for the EU market.