What you need to know about the deal and medicines and medical devices

The Trade and Cooperation Agreement

The Trade and Cooperation Agreement (TCA) between the EU and UK will have a significant impact on the medicines and medical device sectors, particularly in the context of regulation. Companies in both sectors need to review their existing arrangements to see if adjustments are required as a result of the reduced regulatory recognition between the EU and UK under the TCA. A number of the key changes and impacts are summarised below.

Medical devices and IVDs

As anticipated, the TCA does not specifically cover medical devices or in vitro diagnostic medical devices (IVDs). This means that there is currently no mutual recognition of medical devices legislation between the EU and UK, so the medtech industry is effectively dealing with “hard Brexit”. Consequently, medical device and IVD manufacturers, authorised representatives, importers and distributors operating in the EU and UK must now comply with two separate regulatory regimes.

UK position: Following the UK Medicines and Healthcare products Regulatory Agency (MHRA)’s guidance, Great Britain (GB) (i.e. England, Wales and Scotland) will continue to recognise the CE marking and CE certificates of conformity issued by EEA based Notified Bodies until 30 June 2023. After this date, in order to place a medical device or an IVD on the market in GB, a new regulatory route to market culminating in a UKCA (UK Conformity Assessed) mark will replace the CE mark. In Northern Ireland, EU medical devices legislation will continue to apply, with the same timings for the implementation of the MDR and IVDR as in the EU. Subject to various grace periods, all medical devices or IVDs placed on the UK market need to be registered with the MHRA. Manufacturers are also required to either have a legal presence in the UK or to appoint a UK-based responsible person (UKRP). The UKRP assumes the responsibilities of the manufacturer in relation to the registration of the devices.

EU position: Since 1 January 2021, all authorised representatives established in the UK and CE certificates of conformity issued by UK notified bodies are no longer recognised in the EEA. As a result, manufacturers of medical devices or IVDs for the EU market that have a UK authorised representative or notified body need to switch to an authorised representative or notified body in the EU.

Medicines

The TCA includes a sector-specific annex that provides a framework for the mutual recognition of Good Manufacturing Practice (GMP) inspections by competent authorities in the EU and UK, and for the exchange and acceptance of official GMP documents. However, this framework does not extend to other key regulatory areas such mutual recognition of as batch release certification or Good Clinical Practice inspections.

UK position: The MHRA will continue to recognise QP certification for batch release conducted in jurisdictions on the ‘approved country’ list, which includes all EEA member states, for products placed on the UK market before January 2023. UK-based entities must appoint a ‘Responsible Person for import’ (RPi) to perform certain checks on the imported medicinal products prior to placing them on the UK market, such as confirming that QP certification has taken place.

EU position: The UK is now regarded as a third country meaning that all final batch certification and subsequent release decisions for the EU can no longer occur in the UK as the EU has not agreed to continue to recognise UK testing and certification.  As a result, any marketing authorisations for EU member states that include a UK batch release site need be varied to include a batch release site within the EU.

For a more detailed discussion, please join us for our webinar at 12pm UK/1pm CET on 14 January 2021 where members of our Brexit taskforce will discuss the key implications of the TCA and how our clients can best plan for the future.