Uncertainty for MedTech – Notified Bodies and Brexit in 2019

As the United Kingdom delves deeper into political uncertainty, many organisations are left wondering what effect the unforeseen Brexit deal will have on Medical Devices and Notified Bodies in 2019.

The Medical Devices Directive, In-Vitro Diagnostic Devices Directive and Active Implantable Medical Devices Directive have been instrumental in the deployment of exemplary medical devices for over 25 years, but the withdrawal of the UK from the European Union has the potential to disrupt this.

Whilst the MHRA has stated that the soon to be implemented Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation (IVDR) texts will be transposed into the UK Statutory Instruments, Brexit still may have a significant impact on our ability to access innovation and products in the Medical Technology and Devices industry. Unpredictability may be detrimental to businesses and legal uncertainty would also be damaging.

Manufacturers within the UK are at risk of facing a reduced number of Notified Bodies to register, approve and certify products; these services are vital for products getting to the market. This capacity will not be replaced easily and its effects are being felt already. Manufacturers are already experiencing time delays in obtaining market authorisations before European Notified Bodies are able to pick up what has been left. Manufacturers would need resources and time to adjust themselves to the requirements of unfamiliar Notified Bodies and the delays could be significant.

UK based manufacturers may also risk losing their access to the European market, leading to major interferences for UK products getting to EU patients and suppliers. Japan and the US based manufacturers currently experience these delays; the UK could expect a similar turnaround following Brexit.

Time delays of this nature has potential to increase the cost of supply to patients who may have to adapt to new products if existing ones become unavailable. The impact of this may affect the price of products, safety of patients and the scope for Medical Device organisations to expand and employ more people.

Disbandment between the UK and the EU could lead to devices that have been CE marked in the UK needing to go through the process of retesting – an outcome that appears more likely after the introduction of the UK specific trademark announced recently. On another note, the EU would also lose UK expertise and data and vice versa; the separation of relationship would likely be counter-productive for all parties involved in the Medical Devices supply chain.

Whilst the above points are all potential impacts of Brexit, it is impossible to state for certain what will happen to the Medical Devices industry, or in the UKs business and political landscape generally following the result of the deal.

Procorre currently work with a large quantity of Medical Device experts, Notified Bodies and manufacturers navigating legislative and industry change. We can supply our partners who are subject matter experts in this field to help move your business forward and navigate any concerns that you have in the face of uncertainty.

Contact myself or Matthew O’Donnell today to arrange an initial gap analysis and discuss your business requirements with Procorre’s expert team.

Written by Paul Fletcher-Dyer