MHRA Publishes Draft Statutory Instrument for Future Regulatory Framework for Medical Devices

By Karen Hill

After much anticipation, on May 8, 2026, the Medicines & Healthcare products Regulatory Agency (MHRA) published the long-awaited draft Medical Devices (Amendment) Regulations 2026 on the World Trade Organization (WTO) notification portal. Referred to as “the 2026 Regulations”, this draft statutory instrument for the future regime builds on earlier public consultations and engagement. It focuses on delivering closer international alignment and introduces international reliance routes, as well as strengthening requirements for custom-made devices, software as a medical device (SaMD), and in vitro diagnostic (IVD) devices.

In this update we discuss the proposed changes to pre-market regulatory requirements for both medical devices and IVDs in Great Britain (GB), and the impact these will have on manufacturers placing devices on the market. 

International alignment

The 2026 Regulations revise and introduce a number of key definitions to ensure they are appropriate and more closely aligned with international definitions. The 2026 Regulations also refine and add to the existing essential requirements – a list of requirements that manufacturers must meet in order to support the safety and performance of medical devices  – to provide more detailed requirements that keep pace with technological progress and closer alignment to international best practices.

International reliance

The MHRA first introduced its policy intent for International Reliance in May 2024 to improve access to safe, quality-assured medical devices for patients in GB, by reducing duplication of regulatory assessments where safe to do so and making use of the expertise and decision-making of other regulators. The MHRA has now confirmed three comparable regulator countries (CRCs): Australia, Canada and the USA. The three proposed international reliance routes would rely on the approvals or certificates issued by the regulatory authorities in these CRCs subject to certain conditions and requirements. 

As previously indicated, there is no provision for the indefinite recognition of CE-marked medical devices, which under the current transitional arrangements will continue to be accepted in GB until June 2028 or June 2030, depending on the specific device. However, it is anticipated that medical devices complying with the EU MDR or EU IVDR will be permanently accepted on the GB market, following the outcome of the MHRA’s targeted consultation, which ended in April.

Custom-made devices

Custom-made devices will require more comprehensive technical documentation and identifiers to enable identification throughout the supply chain, improving both traceability and patient safety. In addition, prescriptions for custom-made devices will be able to be provided electronically, and Class IIb or Class III custom-made implantable devices will require a quality management system (QMS) certified by an approved body. 

Software as a medical device

The new legislation will establish cybersecurity requirements for software to align with international best practices. It will also introduce predetermined change control plans (PCCP) to streamline the regulatory process, allowing for pre-identification and management of specific change events, thereby reducing administrative burdens for both regulators and manufacturers and supporting improved product lifecycle management processes.

Regulation of IVDs

As previously indicated, the existing IVD classification system will be revised to ensure that IVDs are classified appropriately according to risk. This will also align GB more closely with the structure used by the IMDRF and EU, in an effort to support global harmonization. 

Certain high-risk Class D IVDs will be required to meet stringent safety and performance requirements to protect patient safety where there is high patient risk. This will also harmonize regulatory requirements with Northern Ireland, which follows the EU IVDR.

Lastly, the need for separate validation of COVID-19 tests that have already met the common specifications requirements will be removed, thereby streamlining the regulatory process, avoiding duplication, and reducing burden on businesses. 

Stakeholder Impact Survey

In addition to publishing the new regulations, the MHRA are also seeking stakeholder evidence on the proposed changes to inform impact assessment. The survey seeks to gather evidence on the practical impacts of the proposed pre-market changes, including likely costs, benefits, and implementation considerations. Patients and patient representative organizations, healthcare professionals and healthcare providers, medical device manufacturers and suppliers, UKRP, as well as trade bodies and other interested organizations are invited to share their views and experiences that are relevant to their organization, in a business and stakeholder impact survey which is now open and closes at 11:59 pm (UK time) on June 19, 2026. 

Next steps/timeline

Given that draft legislation must be notified to the WTO and opened for comments at least 60 days before being laid in Parliament, and the MHRA’s Stakeholder Impact Survey does not close until mid-June, it is possible that further updates to the proposed legislation may be required in the coming months, further delaying its implementation. Once approved, the SI will come into force six months later and it is predicted that the new legislation will not be implemented before early 2027, with up to a 3-year transitional period for medical devices and 5-year transitional period for IVDs.   

Concluding remarks

The MHRA believes that the 2026 Regulations strengthen safe access to medical devices, support innovation, and align GB’s medical device framework with international best practices. Here at Emergo by UL, we welcome these updates and look forward to seeing them implemented in the not-too-distant future and, as always, we will keep you informed of any further updates as and when they arise.