Our Priorities International


Brexit Picture

Brexit is a critical topic for the medical technology industry which has developed highly complex ties between the United Kingdom (UK) and the rest of the EU. Medical technologies are often moved between different EU countries during their production lifecycle and their clinical use. Crucially, up to 30% of our industry’s products have been authorised via UK Notified Bodies (CE marking) and could lose such authorisation overnight in the case of a “cliff edge” Brexit. MedTech Europe is tracking developments closely and has produced a position paper and other relevant documents to help medical technology companies to navigate Brexit.

Given the importance of the medical technology industry in maintaining and improving public health, there is a need for sector-specific measures during the ongoing Brexit negotiations between the EU and the UK. Such measures will not only ensure that patients continue to receive timely access to life-saving and life-changing technologies, but also ensure the future global competitiveness of an important sector for the EU economy.

To ensure that patient safety and public health across Europe and the UK are guaranteed, MedTech Europe has identified the following priorities:

  • Formal agreement on an extension of the Brexit transition period which lasts to at least 31 December 2020, taking into consideration the challenges arising from the designation of Notified Bodies during the implementation of the new In Vitro Diagnostics Regulation (IVDR) and Medical Devices Regulation (MDR).
  • Continued authorisation in the EU27 of medical technologies CE-marked by a UK-based Notified Body, through a mutual recognition agreement.
  • Implementation of a trade agreement for healthcare to prevent development of trade barriers which would decrease industry investment capacity in innovation and industrial development.
  • A convergence of regulatory frameworks, particularly the implementation of the new IVDR and MDR for market access to both EU and UK.

MedTech Europe is also part of a Brexit EU healthcare stakeholder group, a coalition of Brussels-based health actors which includes patients, healthcare professionals, academia, hospitals, payers, and the pharma industry which work together to guarantee that decision-makers are clear on what steps are needed to ensure patients are put first.