In a joint letter to the negotiators representing the UK and EU, medical device and in vitro diagnostic industry trade groups have urged both parties to ensure full regulatory implementation in their sector following “Brexit”, in March 2019. The trade groups represented are MedTech Europe (MedTech), the Association of British Healthcare Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA).
The argument centres on the potential negative implications to the industry’s vital contribution to public health if post-Brexit regulatory alignment is not secured. The trade bodies warn that specific measures are needed to maintain access to life saving technologies and ensure the UK and EU’s medical device sectors remain competitive on a global scale in the future.
The letter argues that the European Single Market is vital to the industry’s success, as it creates consistent European regulations throughout the EU, which drives access to high quality, timely and effective care to patients.
What is the problem?
The problem is that the current system is being updated in stages and the UK will only remain subject to such updates until Brexit, in March 2019, whilst new Medical Devices Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulations (IVDR) are not due until May 2020 and May 2022 respectively. This will lead to growing disparity between these regimes in the UK and EU after March 2019. According to MedTech, ABHI and BIVDA, regulatory divergence would have severe financial and bureaucratic costs, impede innovation and industry growth, and restrict access to medical technologies.
Further, the trade bodies argue that any such divergence will weaken collaboration and post-market surveillance data sharing between EU and UK-based organisations, hindering the development of the medical device industry of both parties.
What is the answer?
The trade bodies believe that the answer lies in securing a transitional period to implement secondary legislation and ensure the adoption of the MDR and IDVR, which will maintain vital medical technology supply to patients throughout the UK and EU.
In addition, Medtech, ABHI and BIVDA have laid out five key areas for maintaining regulatory stability that they believe should be included in a post-Brexit agreement:
- The UK must continue to recognize and enforce CE Marking requirements for medical devices and in vitro devices through full implementation of the MDR and 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 Medical and Healthcare products Regulatory Agency should fully and formally participate in the European Commission’s Medical Devices Coordination Group.
- UK regulators should have full access to the European Database for Medical Devices, including pre- and post-market data, economic operator registration data, clinical investigation information and related materials.