EMERGO SUMMARY OF KEY POINTS:

• UK and European medical device and IVD industry trade groups are arguing for full MDR and IVDR implementation in Great Britain during and after Brexit negotiations.
• The groups seek European recognition of UK Notified Bodies and Authorized Representatives as well as full access to the Eudamed database by the UK MHRA.
• Whether Brexit negotiators adequately address the trade groups’ concerns remains an open question.

Medical device and IVD trade groups in Europe and the UK have appealed to maintain a uniform system for CE Marking and regulatory oversight as negotiators work out British withdrawal from the European Union under Brexit.

In a joint letter to UK and European Brexit negotiators, leaders of MedTech Europe, the Association of British Healthcare Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA) argue for ongoing coordination between the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and European Competent Authorities during and after Brexit negotiations. Divergent medical device and IVD regulatory systems, they argue, could compromise public access to medical technologies and hinder regional and global competitiveness for British and European industries.

Five criteria for post-Brexit regulatory stability

MedTech Europe, ABHI and BIVDA officials warn in the letter that without a clear transitional framework established by Brexit negotiators, medical device and IVD regulations in the UK will eventually diverge from those of Europe.

“We believe that any such divergence would be unhelpful, and that, whatever other arrangements may be in place, a transitional period to implement secondary legislation for medical devices and in vitro diagnostic medical devices, and maintain parity of regulation with the EU, is needed,” write the trade group officials.

The letter lays out five critical factors authors believe must be addressed by Brexit negotiators:

• The UK must continue to recognize and enforce requirements of CE Marking for medical devices and IVDs via full implementation of the Medical Devices Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulations (IVDR).
• UK Notified Bodies should retain their designation as European Notified Bodies.
• Authorized Representatives located in the UK should qualify as European Authorized Representatives under the MDR and IVDR.
• The UK MHRA should fully and formally participate in the European Commission’s Medical Devices Coordination Group (MDCG).
• UK regulators should have full access to the European Database for Medical Devices (Eudamed), including pre- and post-market data, economic operator registration data, clinical investigation information and related materials.

“To protect the supply of medical technologies to patients, it will be critical to limit regulatory and administrative barriers for products being moved between the EU and the UK…For our sector, the consequences are disruption to the supply of devices and diagnostics critical to the delivery of modern healthcare, the maintenance of patient safety and the preservation of public health throughout Europe,” warn the trade groups.

As previously discussed by Emergo, however, it remains unclear whether Brexit negotiations will result in mutual UK and European recognition of Notified Bodies and/or Authorized Representatives, or if device manufacturers will have to hire separate entities on either side of the English Channel. These questions, as well as that of whether British regulators will continue to have full access to Eudamed, remain open for the time being.

Related European regulatory resources from Emergo:

• European CE Marking strategy for medical device companies
• European CE Marking strategy for IVD companies
• European Authorized Representative in-country representation
• European MDR 2017/745 gap assessment and transition support
• Whitepaper: MDR transition timelines and strategies
• Whitepaper: Understanding the European IVDR