Recent Updates to Medical Device Regulation in Great Britain
The United Kingdom’s (UK) medical devices regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), carried out a public consultation in late 2021 on the future regulation of medical devices.
The Government response to that consultation was published in June 2022 and describes plans for creating the new medical device regulatory framework within the UK using a phased approach.
New Medical Device Regulatory Framework
Currently in Great Britain (GB), medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
On 27 April 2023, the Medical Devices (Amendment) (Great Britain) Regulations 2023 were published, proposing to amend the UK MDR 2002, to extend the time allowed for CE-marked medical devices to be placed on the GB market.
Following Great Britain’s exit from the EU, medical devices placed on the GB market require either the UK Conformity Assessed (UKCA) or CE mark, depending on the legislation the device was certified under.
These provisions however, will cease to apply from 30 June 2023, and from 1 July 2023, such medical devices would only be accepted if they conform with the UK MDR 2002 requirements and the UKCA marking scheme.
Therefore, the UK medical devices sector needs to transition fully to the UKCA marking system, and the Medical Devices (Amendment) (Great Britain) Regulations 2023 which proposes to amend the UK MDR, aims to allow for additional time to achieve this transition.
Such measures are important in order to ensure future supply and availability of medical devices.
Important Dates of Note
The Medical Devices (Amendment) (Great Britain) Regulations 2023 is made under section 15(1) of the Medicines & Medical Devices Act 2021 (“the MMDA”), and proposes amendments to regulation 1ZA (expiry of certain provisions in these Regulations) of the UK MDR.
It outlines several important dates as follows:
- For custom-made devices that comply with Directive 93/42/EEC (EU MDD) or 90/385/EEC (EU AIMDD) under regulations 19B and 30A of the UK MDR, the date remains 30 June 2023.
- Regulations 19B and 30A of the UK MDR relate to devices that comply with Directives 90/385/EEC (EU AIMDD) and 93/42/EEC (EU MDD) and will cease to have effect on 30 June 2028, or expiry of the conformity certificate, whichever is sooner.
- Regulation 44ZA of the UK MDR relates to devices that comply with Directive 98/79/EC (EU IVDD) and will cease to have effect on 30 June 2030, or expiry of the conformity certificate, whichever is sooner.
- CE marked devices compliant with the EU MDR or EU IVDR will be accepted on the GB market until 30 June 2030, and will cease thereafter.
As noted in the explanatory memorandum to the Medical Devices (Amendment) (Great Britain) Regulations 2023: “If placing medical devices on the GB market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU).”
Overall, this legislation will allow additional time for some CE marked medical devices to be placed on the GB market.
Further legislation is also expected regarding post-market surveillance requirements, as detailed in the Government response from June 2022, and these are anticipated to apply from mid-2024.
‘Core aspects’ of the future regulatory framework of medical devices are anticipated to apply from 1 July 2025.
Finally, guidance documents have been recently updated to reflect the proposed extension beyond 30 June 2023, and further updates are expected to support the interpretation of the new medical device framework.
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Denise McDermott, Senior Compliance Specialist, Compliance & Risks
Prior to joining Compliance & Risks, Denise worked in the medical device industry for 13 years across a number of areas including regulatory affairs, post-market surveillance, customer complaints, quality, and technical support.
She has experience in several areas including IVDR, CE marking, labeling, legal documentation, customer and quality technical communications and regulatory risk assessments.