MedTech Europe’s Position Paper on Article 50 Negotiations between the European Union and the United Kingdom (Brexit) outlines potential multiple consequences of Brexit for the medical technology industry and proposes solutions for risk mitigation.

A key concern highlighted is the implications for manufacturers, distributors, suppliers, hospitals, and patients of two divergent regulatory systems, particularly regarding the newly adopted EU Medical Devices and In vitro Diagnostic Medical Devices Regulations. The paper recommends that UK law should fully implement the provisions of these Regulations to have full alignment with the EU-27 as well as including the provisions of other relevant regulations where necessary to ensure patient safety and frictionless trade.

The paper warns of potential delays, tariffs and problems with access to the market post-Brexit and suggests that specific customs arrangements should be put in place to minimise the impact of the UK’s withdrawal from the EU on the medical technology sector, and ultimately on patients’ safe access to treatments.

The paper emphasises that predictability is of utmost importance to businesses and that legal uncertainty in any form would be detrimental; therefore in the Brexit negotiations, both parties need to work constructively and swiftly to deliver clarity regarding transitional arrangements, aiming to minimise disruption and cost.

The Association of British Healthcare Industries (ABHI) had contributed to the Paper and has welcomed its publication. Richard Phillips, Director, Healthcare Policy at the ABHI said “We are pleased to see that our colleagues in Europe are broadly aligned to our own messages and we will continue to work … so that the UK can develop successful international relationships, increase efficiency of healthcare delivery and improve patient outcomes.”