Detailed guidance has been released by the MHRA outlining the various requirements needed to place a medical device (including in vitro diagnostic and active implantable devices) on the UK market after Brexit.
The document principally highlights the differences between governance of the medical device market in Great Britain (England, Scotland, Wales) and in Northern Ireland (NI). It also details requirements for GB manufacturers wishing to place a device on the EU market.
The EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), which will apply in EU member states from May 2021 and May 2022 respectively, were not automatically retained by the EU Withdrawal Agreement Act and therefore are not applicable in GB after Brexit. Consequently, the UK MDR 2002 remains the primary legislation that regulates devices in GB. Manufacturers wishing to place a device on the GB market need to register with the MHRA. If they are based outside the UK, they must appoint a single UK Responsible Person (RP) who will take responsibility for the product in GB.
From 01 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the GB market, need to be registered with the MHRA. There is a grace period for registration based on device classification:
- Class III and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 01 May 2021
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 01 September 2021
- Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022
Manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (UK-based manufacturers or third country manufacturers with NI based Authorised Representatives), must continue to register their devices from 1 January 2021 on the same basis as they do now, rather than in line with the aforementioned dates.
The EU no longer recognises UK Notified Bodies, meaning they can’t issue CE certificates (other than for the purposes of the “CE UKNI” marking, which is valid in NI) and have become UK approved bodies. However, CE marking will continue to be recognised in GB until 30 June 2023 and certificates issued by EU-recognised Notified Bodies will continue to be valid for the GB market until 30 June 2023. UK approved bodies can be used to label devices with a UKCA mark which is required to market new devices in GB. Vigilance reports as part of post-marketing surveillance must be submitted to the MHRA for devices in both GB and NI.
Principally, NI is more closely aligned with the EU. The EU MDR and EU IVDR will apply to NI from their respective dates of implementation. Consequently, CE marking is required to place a device on the NI market and if a UK Notified Body undertakes mandatory third-party conformity assessment then a UKNI mark is required. GB based manufacturers must appoint an EU or NI based Authorised Representative in order to place devices on the NI Market.
Unfettered access provisions granted by the UK Government mean that NI manufacturers can continue to place CE and CE UKNI marked devices on the GB market after 30 June 2023. For all devices, whether on GB or NI markets, manufactures must submit vigilance reports to the MHRA.
GB manufacturers wishing to place a device on the EU market must obtain a CE mark as a UKCA mark is not recognised by the EU. Devices placed on the EU market before 1 January 2021 by a UK-based Notified Body may remain, however they no longer have the ability to confer a CE mark. All new devices must be assessed by an EU-recognised Notified body.
Furthermore, GB based Authorised Representatives are no longer recognised in the EU. This means GB based manufacturers wishing to supply CE-marked devices to the EU and manufacturers outside the EU who only have a GB based Authorised Representative are required to appoint one based in the EU or NI.
Click here to access the guidance.