On 11 May 2026, the Medicines and Healthcare products Regulatory Agency (“MHRA”) opened a call for evidence on proposed changes to pre-market medical device and in vitro diagnostic medical device (“IVD”) requirements in Great Britain (“GB”) under the Medical Device Regulations 2002 (“2002 Regulations”). The proposals are set out in the newly published draft Medical Devices (Amendment) Regulations 2026 (“Amending Regulations”). This call for evidence forms a critical part of the UK government’s process for assessing the real‑world implications of a major reform of GB’s medical devices regulatory framework.

These long awaited proposals, as referred to in the MHRA Roadmap published in December 2024, follow previous amendments made to the 2002 Regulations in June 2025, relating to post-market surveillance. Read about these amendments in our previous blog.

Below, we explain what the call for evidence is, why it matters, and provide an overview of some of the key regulatory proposals that stakeholders are being asked to comment on.

Call for evidence

The current call for evidence requests that stakeholders complete a structured “impact survey” launched by the MHRA to gather views and evidence on the practical, financial and operational impacts of the Amending Regulations. These proposals build on earlier public consultation and engagement. The survey seeks input from a wide range of stakeholders, including manufacturers, approved bodies, healthcare providers, patients, UK responsible persons and trade associations, to inform the government’s impact assessment and implementation planning.

Respondents are invited to provide evidence on the likely costs, benefits, challenges and operational implications of the proposed pre‑market reforms, which aim to strengthen patient safety, improve regulatory proportionality and support innovation in Great Britain. The evidence gathered will be used to assess how the proposed regulatory changes may affect different parts of the medical device and IVD sector before the Amending Regulations are finalised and brought into force. The MHRA has also published guidance for stakeholders to review prior to completing the survey.

The deadline for completing the survey is 19 June 2026.

Key proposals

The Amending Regulations propose a new, standalone Great Britain medical devices and IVD regulatory framework, moving away from the current retained EU-Directive framework and predictably drawing heavily on various provisions of the EU Medical Devices Regulation 2017/745 (“EU MDR”) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (“EU IVDR”), as well as International Medical Device Regulators Forum (“IMDRF”) frameworks.

The Amending Regulations include an extensive package of transitional provisions designed to support continuity of supply while manufacturers and regulators move from the existing GB framework to the new regulatory regime.

We have set out below an overview of some of the key proposals made in the Amending Regulations (note this is not intended to be fully comprehensive and is provided as a summary review).

Definitions

The Amending Regulations introduce new or updated definitions for various terms including ‘medical device’, ‘implantable medical device’ and ‘in vitro diagnostic medical device’ to more closely align with the EU MDR and EU IVDR, though certain differences remain. The terms ‘clinical evaluation’ and ‘Unique Device Identification’ (“UDI”) have been defined, and the definition of ‘intended purpose’ has been updated, again similar to those in the EU MDR and IVDR.  The definition of ‘essential requirements’ has been updated to replace the current Directive-derived essential requirements framework to include direct reference to Annex I General Safety and Performance Requirements under the EU MDR.

Classification Rules

The Amending Regulations propose new classification rules for general medical devices and active implantable medical devices, as set out in Schedule 9.  These rules introduce more granular risk‑based classification schedules, particularly for software, implantables, and invasive/non-invasive devices, and have many similarities to the classification rules under the EU MDR. Unlike the EU MDR, which contains a standalone software classification rule (Rule 11), the Amending Regulations appears to integrate software within the broader active device classification provisions rather than creating a separate dedicated software rule.

The Amending Regulations also propose a comprehensive overhaul of the classification regime for IVDs, as set out in Schedule 23. The revised framework moves GB closer to the internationally recognised, risk‑based structure used by the IMDRF and the EU IVDR, supporting global regulatory harmonisation. In particular, the proposals impose more stringent safety, performance and conformity assessment requirements for high‑risk Class D IVDs, where the potential impact on patient safety and public health is greatest.

Technical Documentation obligations

The Amending Regulations introduce more prescriptive requirements for technical documentation. Under the proposals, manufacturers would be required to prepare, maintain and retain comprehensive, structured and readily searchable technical documentation, that clearly demonstrate conformity with applicable safety, performance and quality requirements. The scope of required documentation is expanded, including direct reference to the documentation listed in Annex II to the EU MDR and, where applicable, software‑specific materials such as PCCPs (see below). Retention periods have also been extended.

The Amending Regulations enhance the MHRA’s powers to request and inspect documentation at short notice, including the ability to require summary versions within defined timeframes. Through the accompanying call for evidence, stakeholders are invited to comment on the practicality, cost and proportionality of these enhanced documentation requirements, particularly for SMEs, legacy products and software‑driven technologies, and on how they will affect compliance processes and market access under the new GB regulatory framework.

Equivalence

The draft Amending Regulations would introduce, for the first time in GB legislation, a more explicit and structured statutory framework governing reliance on equivalence for general medical devices and active implantable medical devices.

Under proposed regulation 9A, manufacturers may be able to rely on clinical data relating to another device as part of their clinical evaluation strategy where they can demonstrate equivalence across technical, biological and clinical characteristics. The proposal largely reflects concepts developed under EU MDR Article 61, Annex XIV and associated MDCG guidance, but adapts them for the GB framework.

The draft provisions require devices to be comparable in design, materials, performance characteristics, principles of operation and clinical use, and to present no clinically significant differences in safety or clinical performance unless the difference has been introduced to improve those outcomes. Manufacturers would be required to document and justify any equivalence claim in a systematic and risk-based manner and retain supporting evidence for prescribed periods.

The proposal is notable because the existing 2002 Regulations does not presently contain a detailed standalone statutory equivalence regime, with equivalence historically arising primarily through clinical evaluation practice, guidance and conformity assessment interpretation.

PCCP for Software

In relation to software, the Amending Regulations introduce the term “pre-determined change control plan” (“PCCP”), which is intended to describe what modifications can be made to the software and how the modifications will be assessed. This is intended to be optional, and must be included in the technical documentation and approved by an approved body. It is intended to support agile development of software medical devices, allowing for certain software changes to be implemented without full re‑certification, provided they fall within an approved PCCP.

UDI requirements

The Amending Regulations introduce an expanded UDI framework, intended to strengthen device traceability and support more effective post‑market surveillance across GB. Under the proposals, UDI requirements would apply more comprehensively, with detailed rules governing when new UDIs must be assigned following changes to a device’s design, intended purpose, software functionality or packaging. For software medical devices, the new regime places particular emphasis on version control and change management, with UDI obligations closely linked to the PCCP mechanism. Manufacturers and UK responsible persons would also face enhanced obligations to submit, verify and maintain UDI data within MHRA systems.

Misleading claims

The Amending Regulations propose explicit controls on misleading or unsubstantiated claims made in relation to medical devices and IVDs. New regulation 19D establishes a clear prohibition on claims or promotional content that may mislead users or patients about a device’s intended purpose, safety or performance. This includes suggesting functions or benefits that cannot be supported by evidence, failing to disclose significant risks, or promoting uses that fall outside the scope of the device’s conformity assessment or clinical investigation. The Amending Regulation gives the Secretary of State, and in practice the MHRA, strengthened oversight powers, including the ability to assess the overall impression created by language or imagery and to require misleading material to be amended or removed.

International Reliance Pathway (IRP)

The UK government’s intention to introduce international recognition of overseas regulatory authorisations and conformity assessments of medical devices has been under review for some time, with proposals outlined back in May 2024 and August 2025 (see our blogs here and here).

The Amending Regulations introduce an International Reliance Pathway (“IRP”) as an alternative route to market for certain medical devices and IVDs in GB. The IRP is intended to enable manufacturers to leverage regulatory approvals already granted by trusted overseas regulators, with the Amending Regulations specifically proposing those in designated comparable regulator countries Australia, Canada and the United States, to support GB market access. Under this pathway, eligible devices are categorised into defined routes based on risk and device type, and manufacturers must apply for a Certificate of International Reliance from an approved body, supported by evidence of overseas authorisation, quality management system certification and relevant post‑market surveillance data. While the IRP allows manufacturers to rely on prior international regulatory assessments, the proposed regulations retain important GB‑specific safeguards, including MHRA oversight, ongoing post‑market surveillance obligations, registration requirements and the ability to intervene where safety concerns arise.

As set out in our previous blog, in February 2026, the MHRA launched a consultation on the indefinite recognition of devices compliant with the EU MDR and IVDR, extending transitional arrangements for legacy devices and creating an international reliance route for certain high risk devices. This closed in April 2026 and the MHRA is yet to publish its formal response to the consultation.

Implant cards

The Amending Regulations introduce new obligations relating to implant cards, requiring certain implantable device information to be provided to patients and retained by healthcare institutions, reflecting a broader emphasis on traceability and patient transparency.