Update on the consequences of Brexit for the medical devices industry

Category: product safety, product liability, compliance Industry: healthcare Author: Year:
Miriam Schuh

The United Kingdom withdrew from the EU on 31 January 2020, the fourth official withdrawal date. The dreaded "Brexit" has now come to pass. The parties were able to avoid a "hard" or "no-deal Brexit" for the time being: the Withdrawal Agreement concluded between the EU and the United Kingdom arranges the legal relationships between the parties through the end of an 11-month transitional period expiring on 31 December 2020. 

This period may be extended once by up to two years, i.e. through 31 December 2022 at the latest. During this transitional period, there will be no radical changes for the medical devices industry, as the United Kingdom will continue to be treated as an EU member state until the period expires. This means that EU law will continue to apply and the United Kingdom will continue to have all the rights and duties of a member state.

However, it must be stressed that the Withdrawal Agreement contains provisions about free movement of goods which are of significance for the medical devices industry as well. For example, the Agreement defines procedures for the exchange of information between notified bodies in the EU and the United Kingdom, which are referred to in the Agreement as "conformity assessment bodies." This term is used not just for the limited number of established notified bodies for medical devices, but rather applies in a general manner to institutions which are authorized to conduct conformity assessment procedures under EU law.

Another aspect of importance for manufacturers is that the Withdrawal Agreement expressly guarantees that devices which were lawfully placed on the market prior to expiration of the transitional period will be allowed to remain on the market even after the transitional period is over. This means that manufacturers and distributors of medical devices can continue to market and sell their medical devices in both the EU and UK markets.

The impact which Brexit will have after the transitional period expires is still unclear. All we have so far is the "Political Declaration," which contains a rough sketch of the conditions for future cooperation between the EU and the United Kingdom. This Declaration allows for the cautious conclusion that the parties will keep regulated industries like the medical devices industry in mind and negotiate these matters extensively in future agreements.

But if no viable agreement is reached by the time the transitional period expires and the "no-deal Brexit" scenario reemerges instead, the United Kingdom would have to be treated as a third country, which could have a negative impact on the medical devices industry, e.g. with respect to the validity of existing CE certificates.

[April 2020]