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Keep pace with the constantly changing regulatory environment – the Brexit impact

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Matija Rupnik, regulatory affairs manager at ArrowFast emphasises the importance of keeping pace with always-changing regulatory landscapes on medical device markets.

The regulatory requirements for medical devices are subjected to ever-changing regulatory landscapes in different markets. For the manufacturers of medical devices, this represents a constant challenge of maintaining market compliance to keep devices on the market. The upcoming end of the Brexit transition period on 31st December 2020 will bring many changes in the UK, including a new regulatory environment for medical devices.

The market surveillance of medical devices in the UK will continue to be performed by the Medicines and Healthcare products Regulatory Agency (MHRA). From 1st January 2021 onwards, new rules will apply to medical devices. The MHRA has published guidance providing information on how the UK system will operate and how the different rules will apply for Great Britain (England, Wales and Scotland), Northern Ireland (which will have a special status) and the EU.

Legislation

Currently, medical devices in UK are regulated under the existing EU legislation (MDD[1], IVDD[2] and AIMDD[3]), which will continue to apply in Great Britain after 31st December 2020. This is because the UK has planned to adopt any EU legislation that came into force during the Brexit transition period into its own laws under the EU Withdrawal Agreement Act. With the EU delaying the date of application of MDR[4] and IVDR[5], neither legislation will take effect before the end of the transition period and will therefore not automatically apply in Great Britain. What the final legislation covering medical devices in the UK will look like is therefore still not clear, but the MHRA guidance outlines proposals that will take effect through legislative changes which are still subject to UK parliamentary approval.

Conformity assessment bodies and product marking

The MHRA will be able to designate UK Approved Bodies from 1st January 2021 onwards. The existing UK based Notified Bodies which are designated under the current legislation will be automatically designated, without having to undergo a new designation process. The UK Approved Bodies will be able to perform conformity assessment procedures in relation to the new UK Conformity Assessed (UKCA) mark but will no longer be able to issue conformance certificates for the CE mark.

The UKCA mark is a new product marking that will be used for medical devices (among other products) being placed on the Great Britain market after the transition period. While the UKCA mark will be recognised in England, Wales and Scotland, it will not be recognised in Northern Ireland and in the EU. For those markets, a CE mark will still be required. CE mark certificates and the certificates issued by EU-based Notified Bodies (including MDR and IVDR) will continue to be accepted in Great Britain and will remain valid until 30th June 2023. After that date, the UKCA mark will be required for all medical devices sold in Great Britain.

Registration

All manufacturers wishing to place a medical device on the UK market will need to register with the MHRA from 1st January 2021 onwards. Registration will also be required for already certified devices, but since this is considered an extension of the existing registration, there will be a grace period to allow time for compliance with the new registration process. The grace period is based on the risk class of devices. There will be a grace period of:

Registration with the MHRA will be required for both UKCA and CE marked devices. In order to register, the manufacturer will need a registered place of business in the UK, or, designate a UK Responsible Person that has a registered place of business in the UK. This UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.

Conclusion

The regulatory environment in the UK will be subject to changes in the next few years, until the complete new regulatory regime is developed. This requires manufacturers to keep their focus on the compliance of their products intended for the UK market, preferably through an established strategy for a regulatory compliance, and following the changes published in the MHRA guidance.

[1] Medical Device Directive 93/42/EEC

[2] Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

[3] Active Implantable Medical Devices Directive 90/385/EEC

[4] EU Medical Device Regulation 2017/745

[5] EU In-vitro Diagnostics Regulation 2017/746

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