The United Kingdom (UK) officially left the European Union (EU) on 31 January 2020. According to the withdrawal agreement, it is now officially a third country to the EU and no longer participates in EU decision making. The agreement established a transition period that ended on 31 December 2020.1 As a result, the Medicines and Healthcare products Regulatory Agency (MHRA) is now responsible for regulating medical devices in Great Britain (GBR; England, Scotland, and Wales).
Having the UK separate from the EU leaves medical device manufacturers trying to understand additional regulations, how and where they apply, and what they need to do to comply with them.
GBR will continue with the following regulations:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
Due to the Belfast/Good Friday Agreement of 1998 and to preserve the free flow of goods between Ireland and Northern Ireland (NI), NI will follow the regulatory guidance of the EU Commission including the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR) from 26 May 2021 and 26 May 2022, respectively; however, they still must register with MHRA.
The UK will continue to recognize CE marking until 30 June 2023. If you already have a valid CE marking on your device, you are not required to re-label the device with a UK Conformity Assessed (UKCA) mark until 1 July 2023 for placement on the GBR market. However, the UKCA mark will be required on devices on the GBR market beginning 1 July 2023. Devices can have both the CE and UKCA marks present on the labeling prior to 1 July 2023, and dual marking will continue to be accepted on the GBR market after 1 July 2023. The EU Commission has not weighed in on allowing a UKCA mark on the label with the CE mark. NI will still require a CE mark throughout the transition and after July 2023.
GBR is no longer using the EU-approved notified bodies and has established UK-approved bodies to perform this function. As of 7 January 2021, the UK‑approved bodies include BSI Assurance UK Ltd, SGS United Kingdom Ltd (0120), and UL International (UK) Ltd (0843).2
Another important change is that all new medical devices, including in vitro diagnostic medical devices (IVDs), placed on the GBR market need to be registered with the MHRA. Manufacturers based outside the UK that want to market their device in GBR need to appoint a representative located within the UK who will take responsibility for the product in GBR and register it.
The grace periods for registering medical devices with MHRA are as follows:
- Class IIIs and Class IIb implantables and all active implantable medical devices and IVD List A products must be registered from 1 May 2021.
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 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.
The following requirements apply to manufacturers that plan to place medical devices on the NI market:
- Certain medical devices, including IVDs, placed on the NI market will also need to be registered with the MHRA.
- Class I devices and general IVDs placed on the market by NI manufacturers and Authorized Representatives based in NI must be registered as they were prior to 1 January 2021.
- For other device classes, devices must be registered with MHRA by the dates below:
- Class IIIs and Class IIb implantables and all active implantable medical devices and IVD List A products must be registered from 1 May 2021.
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021.
- When placing devices on the NI market, GBR-based manufacturers must appoint an EU- or NI-based Authorized Representative.
In summary, the regulations for EU, UK, and NI differ and new guidances have been released with additional guidances and updates expected. If you need assistance with understanding or implementing the regulatory changes for the UK, NI, or the EU, contact us through:
参照文献
- What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) Markets. Regulating medical devices in the UK 2020; https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk. Accessed 2021, 2021.
- UK approved bodies for medical devices. 2021; https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices. Accessed 5 April 2021, 2021.
