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The precise impact of a vote for Brexit is currently still uncertain. It would fundamentally change the nature of the UK’s relationship with the rest of the EU and the world and may also result in significant changes for those doing business in the UK. However, these changes may be particularly relevant to the pharmaceutical and medical device industries.
Brexit would also bring into question the large amounts of UK law based on EU rules. In each area, the UK would need to decide whether to continue to follow the EU lead or go its own way and may risk damaging trade with the EU which is currently based on the adoption of consistent EU wide standards.
Moreover, even if the UK were to decide to continue to follow the EU lead this may, in some circumstances, be insufficient to permit the continued marketing of UK products in the EU. As an example, the pharmaceutical and medical device sectors are among the most highly regulated in the EU.
Currently, the demonstration of compliance with related legal obligations permits UK manufacturers to market their products throughout the EU.
Brexit would mean that UK manufacturers would no longer be bound by related EU legal obligations. Also, the laws governing pharmaceutical products and medical devices following Brexit would be UK-specific laws, rather than current or future EU laws. Consequently, a voluntary undertaking by UK manufacturers following Brexit to continue to comply with EU obligations may be considered insufficient to support a claim of compliance with related legal obligations.
The right for medical device manufacturers to affix a CE mark to their products is based on demonstration of compliance with the obligations laid down in the EU medical device directives and related guidance documents that are currently the basis of related UK law. Brexit would mean that UK medical device manufacturers would no longer be permitted 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. Like all other non-EU manufacturers, in order to continue to market their products within the EU, UK manufacturers would be required to appoint a European Authorised Representative established within an EU Member State. In addition, UK notified bodies would no longer be entitled to conduct a conformity assessment on the basis of the Directives. As a result, manufacturers working with UK notified bodies in relation to the conformity assessment of their medical devices would 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.