Brexit and the availability of medical devices

Brexit and the availability of medical devices

Fimea is the Finnish national authority tasked with the supervision of medical devices. The authority works in close cooperation with the other EU member states’ national authorities and the European Commission. Once implemented, the United Kingdom’s departure from the EU (Brexit) represents a challenge for all medical device supervisory authorities. Discussions are currently ongoing to establish a set of common approaches and to put in place the necessary practical arrangements in response to Brexit in line with current legislation.

All medical devices placed on the EU market must comply with the relevant regulatory requirements, and all manufacturers must have an authorised representative based within the EU. As the base for a significant number of industry operators, including medical device manufacturers, the United Kingdom plays a significant role in this industry. UK-based conformity assessment bodies currently verify 30–40% of all medical devices placed on the market in the EU. The United Kingdom is also home to a significant number of legal service providers working on behalf of non-EU medical device manufacturers.

If the UK exits the EU under a no-deal scenario, the status of businesses and other organisations based in the UK is set to change with immediate effect. According to a strict interpretation, this would also leave some medical devices non-compliant with EU regulations. As such, these devices should no longer be placed on the EU market. According to the current interpretation, a no-deal Brexit will also affect the validity of certificates issued by notified bodies.

A number of industry operators are in the process or have already relocated their operations from the UK to other EU member states. These measures are designed to ensure the continued availability of medical devices. It is expected that the most significant issue, in both practical and regulatory terms, will be ensuring that interim regulatory arrangements are in place for medical device manufacturers whose devices are assessed by notified bodies in the UK until another notified body has been appointed by the manufacturer.

Fimea recommends that, in view of Brexit, healthcare providers take immediate steps to evaluate the availability of medical devices required for service delivery and consider the use of alternative products. We will continue to work closely with the EU authorities and provide further updates as the situation develops.

The European Commission has published a questions and answers document: Questions and answers related to the United Kingdom’s withdrawal from the European Union with regard to industrial products.