September 15, 2025
On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released its response to the public consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices. This is the latest step in the MHRA’s ongoing efforts to revise how medical devices are regulated in the UK.
Background
While serious discussion about the changes to medical device rules began in 2021, activities ramped up beginning in 2024. In January 2024, the MHRA released a roadmap for new medical device regulations, which outlined a path to update the UK’s medical device regulatory framework. New post-market surveillance requirements for medical devices entered into force on 16 June 2025 under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
The MHRA’s consultation on pre-market measures was published in November 2024 and closed on 5 January 2025. The MHRA’s response to the consultation outlines additional changes it intends to implement in the short term.
Key points
The MHRA consultation focused on four areas related to pre-market regulations, including international reliance, UKCA marking, in vitro diagnostic devices (IVDs), and assimilated EU law.
Acknowledging the time-sensitive nature of the four pieces of assimilated EU law considered in the consultation, the MHRA published a response addressing the laws specifically on 26 February 2025. The four laws were set to sunset on 26 May 2025, but no new replacement UK regulations had not been developed. The MHRA proposed to remove the revocation date for these laws so they continue to apply in Great Britain (GB) until they are replaced with UK law. The legislation to do so entered into force on 24 May 2025.
The assimilated EU laws in question covered common technical specifications for IVDs, electronic instructions for use of medical devices, requirements for medical devices manufactured using animal-derived tissues, and the designation and supervision of approved bodies.
With the matters contained in the assimilated laws already addressed in February, the July response outlined the MHRA’s approach to international reliance, UKCA marking, and conformity assessment routes for IVDs.
Regarding international reliance, the MHRA proposed to rely on the approvals or certificates issued by the regulatory authorities in Australia, Canada, the EU, and the U.S., which have comparable systems to GB. Devices would need to be registered with the MHRA and meet GB-specific requirements or have a valid international reliance scheme in place as an alternative to the UKCA process. The GB requirements include the need for English language labelling and packaging, a UK Responsible Person, and a unique device identifier (UDI).
Devices also need to comply with post-market surveillance (PMS) requirements. The MHRA intends to issue a further consultation on the indefinite recognition of CE-marked medical devices after many stakeholders requested an extension.
In the consultation, the MHRA also proposed removing the requirement for a UKCA marking in favour of requiring manufacturers to assign UDIs to medical devices before they are placed on the GB market to improve device traceability. After they have been through the UK conformity assessment process and been assigned a UDI, the UDI must be searchable in a public-facing database.
Finally, in its response the MHRA proposed amendments to the conformity assessment routes for IVD devices in GB to a more risk-proportionate system. The biggest change will be for Class B devices, which will require both a UKCA self-declaration of conformity and Quality Management System (QMS) certification to ISO 13485. The QMS certification may be issued by bodies accredited by the UK Accreditation Service (UKAS) or the International Accreditation Forum (IAF).
Looking ahead
The MHRA intends to meet the objectives set out in its response to the consultation through amendments to the Medical Devices Regulations 2002 (UK MDR). This includes developing pre-market legislation to address changes to international reliance, IVD conformity assessments, and assigning a UDI to devices.
The requirement for a UKCA marking will be introduced with separate legislation, which will come into force after the UDI database is operational and the transitional period for the introduction of UDI has concluded. Additionally, while the MHRA intends to publish a consultation regarding the approach for CE-marked medical devices in late 2025, these devices will continue to be accepted in Great Britain until June 2028 or June 2030, depending on device type.
Medical device manufacturers should closely monitor MHRA communications for updates on amendments to the UK MDR and any subsequent guidance documents that may help them prepare for the new obligations. They should also take any future opportunities to provide feedback on the CE mark consultation, as the MHRA seems responsive to industry input.
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