Breaking it down: Brexit and medtech

Brexit could result in uncertainty over key elements of the medical devices regulatory regime. Counsel Fabien Roy from legal expert Hogan Lovells examines the potential implications of Brexit for medical device companies.

Access to the EU market

The right for medical device manufacturers to affix a CE Mark to their products is based on their demonstration of compliance with the obligations laid down in the EU medical device Directives and related guidance documents that currently form the basis of related UK law.

Brexit will mean that UK medical device manufacturers will no longer be able to take advantage of the right to claim automatic entitlement to market medical devices throughout the EU on the grounds that they have conducted a conformity assessment on the basis of EU device rules and affixed the CE Mark to their devices.

Similarly, the CE Mark affixed to a medical device on the basis of the EU legislation may not necessarily be sufficient to market a medical device in the UK if different or additional requirements apply in the UK, post-Brexit.

UK authorised representatives

The current Directives on medical devices provide that companies that do not have an establishment within the EU and who wish to affix a CE Mark to medical devices and to market these products in the EU must either: (i) establish an EU presence; or (ii) select a local representative to serve as its "Authorized Representative".  

When the UK leaves the EU, depending upon the exact terms of the UK's withdrawal, UK medical devices manufacturers, might, like all other non-EU manufacturers, be required to appoint an Authorized Representative established within an EU Member State to allow the continued marketing of their products within the EU. Alternatively, UK manufacturers may choose to establish a presence in one of the EU Member States and to transfer their responsibility as legal manufacturer of the medical devices to this new address.

As a consequence of Brexit, UK Authorized Representatives may lose their right to be appointed as the point of contact for third country manufacturers with competent authorities in the EU Member States. Manufacturers not established in the EU and which currently work with an Authorized Representative based in the UK may, therefore, also be required to appoint an Authorized Representative established in the EU to continue fulfilling the requirements of the Directives.

UK notified bodies

As a result of Brexit, UK notified bodies such as BSI, SGS United Kingdom Limited, Lloyd's Register Quality Assurance Ltd, Amtac Certification Services LTD, UL International (UK) Ltd. might no longer be entitled to conduct conformity assessment on the basis of the Directives.

Manufacturers working with UK notified bodies in relation to the conformity assessment of their medical devices may be required to appoint a new notified body established in an EU Member State. This is likely to lead to a new conformity assessment to permit the continued marketing of their medical devices in the EU. In light of the current workload of the notified bodies in the EU, which are already preparing for the new Regulations on medical devices, it is expected that Brexit will lead to additional delays in conformity assessment procedures.

Clinical investigations and data privacy

Brexit is expected to have important consequences for the conduct of clinical investigations and data privacy. In the context of on-going clinical investigations conducted in the EU it may be necessary for the informed consent signed by a study subject to be revised to permit the transfer of that study subject's personal data to the UK.

Additionally, if a UK manufacturer is the sponsor of a clinical investigation conducted in the EU, it will be required to designate a Data Protection Representative in each EU Member State where there is a clinical investigation site and where the personal data of the patients is processed. This essentially means that UK companies will be required to appoint a Data Protection Representative in each EU Member State in which an investigational site is established.

When the UK leaves the EU, investigation subjects in the UK will be subject to a new set of data protection laws. These may, particularly in on-going clinical investigations, differ from those referred to in the informed consent signed by the study subjects at the beginning of the investigation. The signature of new informed consents might therefore be required.