Impact of No-Deal Brexit on Medical Devices

The currently expected Brexit day of October 31st 2019 is approaching and with a no-deal or cliff edge Brexit a very real possibility, there are several key areas for medical device companies to consider in terms of impact to their business in the event of a no-deal Brexit scenario. We wish to highlight here two areas for consideration for the medical devices sector:

  1. Non-European medical device manufacturers that currently use a UK based Authorised Representative
  2. Medical device manufacturers who rely on the services of a UK based Notified Body for their certification

Brexit & EU Authorised Representatives

After Brexit on 29th March 2019, the UK will no longer be a Member State of the European Union and will not have direct access to the 27 European Member States. Companies that use a UK based Authorised Representative will be required to have an EU based Authorised Representative. Medical device manufacturers based outside of Europe who currently use the services of a UK based Authorised Representative are advised to consider switching Authorised Representatives as soon as possible. It should be noted that transitioning to a new Authorised Representative involves appointing a new service provider for this purpose but also has implications for labelling, quality systems, registrations in Member States and Certificates of Free Sale among other documentation areas. A streamlined and efficient changeover plan should be discussed with any new Authorised Representative service provider to ensure an orderly transition.

Brexit & Notified Bodies

Medical device manufacturers who rely on the services of a UK based Notified Body for their certification are also potentially heavily impacted by a no-deal Brexit scenario. In the event of a no-deal Brexit, Notified Body certificates issued by UK based Notified Bodies will become void after October 31st 2019. In this event, products covered by UK notified body-issued EC Certificates of Conformity will not be able to be lawfully sold in the EU27 on or after October 31st 2019. BSI has established an operation in the Netherlands and has issued advise to client companies regarding migration of certificates. The LRQA, however, has decided to exit the medical devices notified body sector as we discuss in our video below. For the other Notified Bodies, we understand that they are also involved in establishing operations in EU Member States but that these may not be in a position to issue new certificates in advance of Brexit date of October 31st 2019. This situation is under intense discussion at national and European level as it is recognised that it presents particular difficulties for companies affected. It is possible that transition arrangements may be put in place to allow for the distribution of devices covered by this specific type of certificate for a limited period of time, ensuring a secure transfer of these certificates.

With Brexit day fast approaching, it is important to be prepared for the possibility of a no-deal situation and what it may mean for your medical device supply chain.

  • Does your company currently use a UK based Authorised Representative?
  • Does your company rely on certification issued by a UK based Notified Body?

Acorn Regulatory is assisting clients in preparing for Brexit, assessing the impact of a potential no-deal Brexit scenario, and how to mitigate risks identified. Contact us today to discuss your requirements.

We have written extensively on the subject of Brexit.  You can read all of our coverage on the topic here.

About the Author

Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance. You can read medical device and related articles written by Orla Keane by clicking the link below.
Other articles by Orla Keane

Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues. You can read medical device and related articles written by Bronwyn Kelly by clicking the link below.
Other articles by Bronwyn Kelly