MHRA Guidance on MD Regulations

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority in the sphere of medical devices, has published a guidance document which describes the applicable regulatory requirements, and also provides additional clarifications and recommendations to be taken into consideration by medical device manufacturers, study sponsors, and other parties involved in the supply of medical devices intended to be marketed and used in the UK. This guidance is subject to change as the underlying legislation evolves and in 2025 and 2026, it has been evolving significantly. Manufacturers should treat this as an active framework requiring ongoing monitoring rather than a static reference document.

The document explains what manufacturers need to do to place a medical device on the markets of Great Britain, Northern Ireland, and the European Union (EU). It provides an overview of the UK system as managed by the Medicines and Healthcare products Regulatory Agency, outlining the key processes for device certification, conformity marking, registration, and post‑market obligations.

The guidance is tailored to medical devices – including in vitro diagnostic (IVD) devices and active implantable devices – and clarifies the differences between the regulatory frameworks that apply in Great Britain versus Northern Ireland, as well as the requirements for accessing the EU market.

Overview of the UK Regulatory System

Under the existing legal framework, the MHRA is responsible for regulating medical devices in the UK.

This guidance explains:

• Certification Process: How manufacturers can get their devices certified.
• Conformity Marking: The process for applying the appropriate conformity marks – UKCA or CE – to devices.
• Registration: The requirement to register devices with the MHRA before placing them on the market.

The document emphasizes that the guidance is for medical devices only and does not cover other products that may bear CE or UKCA markings. Manufacturers are encouraged to seek professional advice if there is any uncertainty regarding which regulatory framework applies to their goods.

Market Placement in Great Britain

Since January 1, 2021, several changes, introduced via secondary legislation, have reshaped how medical devices are placed on the Great Britain market (covering England, Wales, and Scotland).

Key elements include:

• UKCA Marking: UKCA marking remains a valid conformity route for the Great Britain market. However, the MHRA is actively consulting on whether to replace the physical UKCA logo requirement with a Unique Device Identification (UDI) system once a national UDI database is operational. Manufacturers should continue to meet UKCA requirements for now while monitoring MHRA announcements on this change.
• CE Marking Transitional Arrangements: The existing transitional timelines remain in place, but are now subject to proposed changes that manufacturers should be aware of. In February 2026, the MHRA opened a public consultation, closing 10 April 2026, on proposals that would significantly extend CE mark recognition in Great Britain:

• Proposal 1: Extend the MDD/AIMDD transitional deadline from 30 June 2028 to 31 December 2028
• Proposal 2: Provide indefinite recognition in Great Britain for CE-marked devices compliant with EU MDR or IVDR — removing the 30 June 2030 sunset date entirely
• Proposal 3: Introduce an international reliance route for devices classified at higher risk in Great Britain than under EU rules

Until these proposals are formally adopted, the existing deadlines remain in force: MDD/AIMDD devices until 30 June 2028, and MDR/IVDR and IVDD devices until 30 June 2030. Manufacturers should monitor the outcome of this consultation closely as it could fundamentally change long-term UK market access strategy.

Registration Requirements

• Every medical device, including custom-made devices, IVDs, and system or procedure packs, must be registered with the MHRA before being marketed in Great Britain. UK-based manufacturers register directly; non-UK manufacturers must appoint a single UK Responsible Person to handle registration on their behalf. A standard fee applies to new registrations and changes.

  Additionally, the MHRA’s July 2025 consultation response proposed amendments to conformity assessment routes for IVD devices, moving toward a more risk-proportionate system. The most notable change is for Class B IVDs, which will require both a UKCA self-declaration of conformity and ISO 13485 Quality Management System certification, a new requirement not previously in force. Manufacturers of IVDs should factor this into their compliance planning.

Role of the UK Responsible Person

The UK responsible person is a designated agent who ensures that all registration and conformity tasks are completed according to the UK Medical Devices Regulations 2002 (UK MDR 2002). This person must have the manufacturer’s authority in writing, maintain key technical documentation (including the declaration of conformity and certificates), and serve as the main liaison with the MHRA.  Using a template for declaration of conformity will help the drafting process.

They are also required to communicate promptly about any complaints or incidents related to the device. It is important to mention that importers and distributors do not have to appoint a UK responsible person unless they are fulfilling that role for the purposes of registration and conformity marking.

Legislation Governing Devices in Great Britain

The regulatory framework in Great Britain is derived from the UK MDR 2002, which was originally enacted to implement EU directives on active implantable medical devices, general medical devices, and in vitro diagnostics. This legislation continues to serve as the basis for conformity assessment and market placement.

A significant development in May 2025 was the removal of the revocation dates for four pieces of assimilated EU law that had been due to sunset on May 26, 2025. These covered common technical specifications for IVDs, electronic instructions for use, requirements for animal-derived tissue devices, and approved body designation. The legislation retaining these provisions entered into force on May 24, 2025 and they continue to apply in Great Britain until replaced by new UK-specific law.

The EU Regulations and Their Application

Although the UK has its own system, the guidance also addresses devices placed on the EU market, explaining the applicability of the EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR). The EU MDR (effective 26 May 2021) and EU IVDR (effective 26 May 2022) now apply to EU Member States and Northern Ireland.

These regulations are not automatically retained in Great Britain. However, transitional arrangements allow devices that have been CE‑marked under these regulations to be accepted on the Great Britain market until the prescribed deadlines (up to 2030 in some cases). The EU notified bodies are essential for mandatory third‑party conformity assessments required for CE marking. UK notified bodies have been re-designated as UK approved bodies and no longer issue CE certificates.

Placing Devices on the EU Market

In this respect, the authority highlights a few key points to be taken into consideration:

• CE Marking: The UKCA marking is not accepted in the EU or in Northern Ireland. To supply devices to the EU, manufacturers must comply with EU MDR or IVDR requirements and affix a CE mark through an EU-recognized Notified Body. Additionally, as of December 2025, the MHRA published an IVD Medical Device Roadmap covering planned regulatory deliverables through mid-2027, which IVD manufacturers targeting both the UK and EU markets should review.
• Authorized Representatives: Great Britain-based authorized representatives are no longer recognized in the EU. Manufacturers must appoint an EU-based or Northern Ireland‑based authorized representative if they wish to place their devices on the EU market.

Additionally, the guidance clarifies that while a device may carry both UKCA and CE markings, the two marks serve different regulatory purposes and must be used in accordance with the market into which the device is being placed.

Conformity Assessment and Product Marking

A key part of market placement is the conformity assessment and appropriate marking of medical devices. The UKCA marking remains the conformity mark for devices on the Great Britain market, demonstrating compliance with UK regulatory requirements. When third-party conformity assessment is required, manufacturers must use a UK Approved Body.

However, the future of the physical UKCA mark is under active review. The MHRA has proposed replacing the UKCA logo requirement with a UDI-based traceability system once the national UDI database is operational. Until that change is formally enacted, the existing UKCA marking requirements remain in force. Manufacturers planning new product development or packaging changes should factor this potential shift into their design and labeling decisions.

For non‑sterile, non‑measuring Class I devices and general IVDs, self‑certification is possible. Devices may carry both UKCA and CE markings provided that both sets of requirements are met.

When dual marking is used, the details of the UK responsible person must appear on the label if the UKCA mark is affixed.

Marking and Transitional Arrangements

CE-marked devices continue to be accepted on the Great Britain market under existing transitional arrangements. Current deadlines remain: June 30, 2028 for MDD/AIMDD-certified devices, and June 30, 2030 for MDR, IVDR, and IVDD-certified devices. However, the MHRA’s February 2026 consultation proposes extending or removing these deadlines entirely for certain device categories, including the possibility of indefinite CE mark recognition for EU MDR and IVDR-compliant devices. The consultation closed April 10, 2026 and outcomes are expected later in 2026. Manufacturers should plan for both the current deadlines and the possibility that they may change.

UK Approved Bodies and Notified Bodies

For devices using the UKCA marking, conformity assessments can be carried out by UK approved bodies. These bodies were formerly UK notified bodies before re-designation. For CE‑marked devices, the conformity assessment must be carried out by an EU‑recognized notified body.

Certificates issued by EU‑based notified bodies remain valid for devices on the Great Britain market under the transitional arrangements.

Registration and Labelling Requirements

Registration with the MHRA is a critical step before any device can be placed on the Great Britain market. All medical devices, including IVDs, custom‑made devices, and procedure packs, must be registered.

For manufacturers based outside the UK, a UK responsible person must be appointed to register the device. A standard fee is charged per application, and the manufacturer (or UK responsible person) must provide all relevant technical documentation, declarations of conformity, and certificates.

Any new registration or changes to an existing registration incur this fee. Without registration, devices cannot be lawfully placed on the market, making strict adherence to these requirements essential.

Devices on the Great Britain market must display either the UKCA or the CE marking, depending on the certification pathway. When applicable, the approved body’s or notified body’s number must be included on the label.

If a UK responsible person is appointed (for non‑UK manufacturers), their name and address must appear on the product labelling, the outer packaging, or the instructions for use – this is required when the UKCA marking is used. Devices bearing both the UKCA and CE marks must ensure that neither mark impedes the visibility of the other.

However, for CE‑marked devices that do not display UKCA, the details of the UK responsible person are not required on the label.

Special Considerations for Northern Ireland

The regulatory framework for Northern Ireland remains distinct. EU MDR and IVDR apply in Northern Ireland, CE marking is mandatory, and the UKCA mark alone is not accepted. These arrangements continue under the Windsor Framework, which replaced the Northern Ireland Protocol.

One practical note for manufacturers: where a device is CE-marked and qualifies as a Northern Ireland good, it can be placed on both the Northern Ireland and Great Britain markets without separate Great Britain registration, a valuable route for manufacturers supplying both markets under a single regulatory pathway.

The guidance outlines several key points for devices placed on the Northern Ireland market:

• EU MDR and EU IVDR: In Northern Ireland, the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR) have been in force since 26 May 2021 and 26 May 2022, respectively. Consequently, CE marking is mandatory.
• Registration Requirements: Certain medical devices, including custom‑made devices, must be registered with the MHRA within 28 days of being made available on the market.
• Authorized Representatives: Great Britain‑based manufacturers must appoint an EU‑ or Northern Ireland‑based authorized representative to supply devices in Northern Ireland.
• UKNI Indication: For devices that undergo mandatory third‑party conformity assessment via a UK notified body, an additional UKNI (UK (Northern Ireland)) marking must accompany the CE mark. However, if self‑certification is used or if an EU‑recognized notified body is involved, the UKNI indication is not required.

Post‑Market Surveillance and Vigilance

After a medical device is placed on the market, ongoing monitoring and vigilance are crucial for ensuring continued safety and performance. Manufacturers must report any incidents or adverse events related to their device to the MHRA.

This requirement is fundamental to ensuring that any safety issues are swiftly addressed. The new post-market surveillance regulations, introduced via the Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024, came into force on June 16, 2025. These are now in effect and are no longer forthcoming.  Manufacturers should already be operating in compliance with them.

The new requirements introduce clearer and more robust PMS obligations, including formal PMS plans, structured adverse event reporting timelines, and for certain risk classes, Periodic Safety Update Reports (PSURs). Manufacturers who had not previously been subject to formal documented PMS requirements in Great Britain should treat compliance as an immediate priority.

Conclusion

The UK medical device regulatory landscape is more active and more consequential in 2026 than at any point since Brexit. For manufacturers operating across Great Britain, Northern Ireland, and the EU, three developments demand immediate attention:

First, the new post-market surveillance regulations are now in force as of June 2025. Compliance is not optional and should already be embedded in quality management systems.

Second, the MHRA’s February 2026 consultation on indefinite CE mark recognition — closing April 10, 2026 — may fundamentally reshape how CE-marked devices are treated in Great Britain long-term. The outcome will influence market access strategy for the majority of manufacturers currently on the Great Britain market.

Third, the MHRA’s international reliance framework, proposed to open in the first half of 2026, will allow manufacturers holding valid authorizations from the FDA, Health Canada, TGA, or EU to use those approvals as the basis for a streamlined Great Britain pathway — potentially cutting time to market by six to twelve months for eligible products.

The regulatory requirements outlined in this guidance are designed to ensure that all devices marketed in the UK meet appropriate safety and performance standards. Staying ahead of ongoing changes to those requirements is itself a compliance obligation.

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As the UK regulatory landscape continues to shift, with new PMS requirements now in force, a live consultation on CE mark recognition, and an international reliance framework coming in 2026, RegDesk ensures your team has real-time visibility into what is changing and what it means for your products. Expanding into new markets has never been easier.