Brexit: What is the impact of the TCA on EU-UK Medical Device regulations?

On December 31, 2020 the transition period during which the UK was still subject to EU law has ended. The long-awaited Trade and Cooperation Agreement signed on December 24, 2020 has been enforced provisionally since January 1, 2021. What does it imply for medical devices regulations?

While the EU-UK TCA is said to have avoided a disastrous no-deal outcome, can it be seen as good news for the harmonization of medical device regulations between the EU and the UK? The answer is no! In this article, we will see what major changes Brexit brings for medical device manufacturers and distributors, despite the signature of the Trade and Cooperation Agreement.

The TCA: no agreement reached on medical device regulations

The TCA guarantees tariff and quota free trade when moving goods across the EU/UK borders (provided the products comply with the “rules of origin” requirements), however, despite this positive outcome for business, no mutual recognition of product conformity assessment has been agreed upon nor any adjustments in Medical Device regulations. Therefore, the EU MDR due to take full effectiveness in May 2021 in all the European Union countries, will no longer apply for Great Britain. As of January 1st, 2021, the UK is considered as a third-party country to the EU, and UK businesses selling in the UK and EU will need to comply with two different regulatory regimes. On its side, the UK has granted a grace period for the enforcement of the new UK registration requirements and the affixing of the UK Conformity Assessed (UKCA) mark but progressively manufacturers and distributors will have to fully comply with the updated UK regulations. As far as the EU is concerned, no grace period has been granted, all EU regulatory requirements are compelling as of January 1, 2021.

The main changes brought up by Brexit for placing a medical device on the market

In the EU

UK Notified Bodies are not entitled any longer to perform assessments of conformity for the EU market. In order to market your device in the EU, manufacturers will have to register their medical device with a EU27 Notified Body.

=> Manufacturers whose products have been certified by a UK Notified Body should have transferred their certification to an EU based Notified Body before December 31, 2020 on the basis of a contractual arrangement between the manufacturer, the UK Notified Body, and the EU Notified Body.

Any manufacturer who did not transfer their certification before January 1, 2021 will have to start a new application to get their products re-certified by an EU Notified Body.

In Great Britain (England, Wales and Scotland)

All devices marketed in Great Britain will have to comply with UK regulations published by the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical devices marketed in the UK. It is the MHRA that is responsible for the designation and monitoring of UK Conformity Assessment Bodies.

The new requirements and regulations for manufacturers who want to place a medical device on the Great Britain market include:

- Registration with the MHRA for all medical devices classes and manufacturers based outside the UK must appoint a single UK responsible person (UKRP).

- The UK Conformity Assessed (UKCA) mark will be mandatory from July 1, 2023. UKCA mark conformity assessments, when required, will have to be performed by a UK Approved Body.

Until June 30, 2022, the UKCA mark is optional as the CE mark will still be accepted on the UK market, as long as the CE marked medical devices meet EU requirements and have a valid EU declaration of conformity or certificate.

- Existing UK Notified Bodies have automatically become UK Approved Bodies on January 1, 2021.

As of today, the MHRA lists 3 Approved Bodies in the medical device field:

- BSI Assurance UK Ltd - 0086

- SGS United Kingdom Ltd - 0120

- UL International Ltd - 0843 (only for certain types of in-vitro Diagnostic Medical Devices)

- Labelling obligations:

From January 1, 2021, to June 30, 2023: CE mark labels will continue to be accepted in Great Britain, and information about the United Kingdom representative (UKREP) will not be required on the labels. When relevant, the number of the Notified Body will have to be visible.

From January 1, 2021: UKCA mark is not mandatory but can be used: if that is the case, name and address of the UKRP must appear on the label as well as the number of the Approved Body (when relevant). Dual marking (CE and UKCA) on the labels will be accepted by the MRHA.

From July 1, 2023: The UKCA mark will become mandatory. However, the MHRA suggests that dual marking (CE and UKCA) will still be accepted.

-> Note that for Northern Ireland where the Northern Ireland Protocol applies, a different guidance has been issued.

The TCA has not provided any agreement when it comes to medical devices regulations and this means more paperwork and additional work for manufacturers and distributors of such devices. However, the TCA is just the starting point of a new era, that will, over time give birth to more EU-UK agreements on individual matters with an acted commitment on both sides to build new regulatory frameworks looking onto international standards. The Pharma and Medical device industry as many others, will pay close attention to all upcoming changes, in order to be able to anticipate and plan accordingly.

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