MHRA releases consultation outcome on future medical device legislation

By Karen Hill

In November 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) opened a public consultation on its proposed amendments to the Medical Devices Regulations 2002 (MDR 2002) relating to international reliance, UKCA marking and the regulation of Class B in vitro diagnostic devices (IVDs). The consultation also sought views on the government’s approach to four pieces of assimilated EU law, which were more time-critical, and therefore the outcome was published on February 26, 2025. The resulting legislation came into force on May 24, 2025.

In this blog, we discuss the outcome of the remaining three aspects of the consultation and its impact on medical device manufacturers placing devices on the market in the UK. 

International reliance

The consultation set out four proposed access routes for different device classes and types to enable quicker market access for certain devices that have already been approved in the comparable regulator countries (CRCs) of Australia, Canada, the EU and the U.S. Having considered the views of all 287 respondents, the government intends to implement three of the four proposed routes to market: Routes 1, 3 and 4.

Additionally, the proposed scope of Route 4 will be expanded to include software as a medical device and implantable Class IIb and Class III medical devices that comply with 510(k) legislation in the US, subject to the demonstration of ‘entire equivalence’ as described in Annex C of the consultation.

In response to the recurring requests to indefinitely extend the recognition of CE-marked medical devices and to deliver uninterrupted market access to devices, the approach for CE-marked medical devices will undergo further consultation and the proposed routes for CE-marked devices will not be implemented at this time. Although the recognition of CE-marked devices will not be included in the new “Pre-Market” legislation anticipated to be released later this year, under the current transitional arrangements, CE-marked devices will continue to be accepted in GB until June 2028 or June 2030, depending on the specific device.

To support the introduction of these reliance routes, guidance will be created that addresses specific questions raised during the consultation.

UKCA marking

The consultation sought views on the removal of UKCA marking on medical devices and their associated labeling, which have undergone the UK conformity assessment process due to the intention to require manufacturers to assign Unique Device Identification (UDI) to their devices before they are placed on the Great Britain (GB) market. Given that most respondents expressed support for this proposal, the government intends to proceed with removing the requirement for UKCA marking, conditional on manufacturers assigning UDI to the device, and the UDI being searchable in a public-facing database. This policy change will therefore only be implemented after the updated database is operational and the transitional period for the introduction of UDI has concluded.

To reduce the burden on manufacturers to relabel products that bear the UKCA mark, this update would be optional and there would be no requirement to remove the existing UKCA marking.

Regulation of IVDs

The consultation proposed a more risk proportionate approach to the regulatory requirements for market access for IVDs, by amending the conformity assessment routes for Class B IVDs to require UKCA self-assessment of conformity with the regulations and Quality Management System (QMS) certification to ISO 13485 before they can be placed on the GB market; however, to provide more flexibility and options for manufacturers QMS certification issued by International Accreditation Forum (IAF) accredited certification bodies from Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) countries as well as QMS Certification from UKAS accredited bodies will be permitted.

In addition, the MHRA is continuing to evaluate the feasibility of recognizing the Medical Device Single Audit Program (MDSAP), and a further update on this will be provided soon. The transition period will be commensurate with the scale of the changes and comprehensive guidance will be published. Lastly, Class A and B IVDs will remain in scope of the international reliance scheme.

Next steps

Amendments relating to international reliance and IVD devices will be taken forward in the “Pre-Market” legislation currently under development, which will be subject to World Trade Organization (WTO) notification requirements and brought into force as soon as Parliamentary time allows thereafter. The draft legislation is expected to be published on the WTO website later this year.

The “Pre-Market” legislation will also introduce the requirement to assign a UDI to a device, with the transitional period for manufacturer compliance being three years for general medical devices and five years for IVDs. In the meantime, the MHRA will continue to develop separate legislation that will remove the requirement for a UKCA marking.

The MHRA will prepare a consultation regarding the approach for CE-marked medical devices.

The future of CE-marked devices

The MHRA believes that these latest developments to the UK legislation will improve patient access to the latest medical technologies available in other advanced countries, as well as boost MedTech industrial growth by reducing duplicative regulatory costs faced by manufacturers. While we at Emergo by UL largely agree with this, we look forward to understanding the MHRA’s concerns around the acceptance of CE-marked devices, which we anticipate will become clearer in the upcoming consultation, of which we will keep you updated.