UK MHRA Med Dev Guidances: Legal Requirements for Specific Medical Products and the Health Institution Exemption

Medical device regulation in the UK is designed to ensure that products placed on the market or manufactured for patient use are safe, effective, and appropriately controlled. While most manufacturers are familiar with the general requirements of the UK Medical Devices Regulations 2002 (UK MDR 2002), certain categories of devices and manufacturing scenarios are subject to additional, specific legal provisions.

Two important MHRA guidance documents explain these areas in detail:

• Medical devices: legal requirements for specific medical products, and

• Health Institution Exemption for general medical devices.

Legal Requirements for Specific Medical Products

The guidance Medical devices: legal requirements for specific medical products provides targeted information for manufacturers of prosthetic, orthotic, and ophthalmic devices, which are considered higher-risk or patient-specific products.

What Are Prosthetic, Orthotic, and Ophthalmic Devices?

• Prosthetic devices are devices that replace a missing body part, such as artificial limbs.

• Orthotic devices are designed to support, align, prevent, or correct deformities or improve the function of body parts, such as braces or supports.

• Ophthalmic devices include products intended for use on or in the eye, such as contact lenses or spectacle lenses.

Because these devices directly affect patient mobility, vision, or anatomy, they are subject to specific legal controls beyond general medical device requirements.

Key Legal Obligations for Manufacturers

The guidance explains that manufacturers of these specific devices must ensure compliance with the relevant essential requirements, including safety, performance, and risk management. Devices must be designed and manufactured so that they perform as intended without compromising patient health.

Manufacturers are responsible for:

• Correct classification of their devices

• Applying appropriate conformity assessment procedures

• Ensuring traceability and documentation

• Meeting labeling and information requirements, including instructions for use

In some cases, these devices may be considered custom-made, which brings additional documentation and declaration requirements. Even when custom-made, manufacturers must still meet safety and performance obligations under the regulations.

Market Placement and Oversight

The guidance clarifies that these devices, when placed on the UK market, are subject to MHRA oversight, including post-market surveillance and reporting of adverse incidents. Manufacturers must have systems in place to monitor device performance and take corrective action when necessary.

Health Institution Exemption (HIE): A Different Regulatory Pathway

While the first guidance focuses on manufacturers placing devices on the market, the Health Institution Exemption for general medical devices addresses a different scenario—where health institutions manufacture devices for their own use.

The Health Institution Exemption recognises that hospitals and healthcare providers may need to manufacture certain devices internally to meet specific patient needs that cannot be addressed by commercially available products.

What Is the Health Institution Exemption?

The Health Institution Exemption allows health institutions, such as NHS hospitals, to manufacture and use general medical devices without fully complying with all regulatory requirements that apply to commercial manufacturers—provided strict conditions are met.

This exemption does not allow free or unregulated manufacturing. Instead, it provides a controlled pathway focused on patient safety, clinical justification, and quality oversight.

Conditions for Using the Health Institution Exemption

According to the guidance General information on the Health Institution Exemption, a health institution may rely on the exemption only if:

• The device is manufactured and used within the same health institution

• The device is not transferred to another legal entity

• The device is manufactured under an appropriate quality management system

• There is a documented clinical justification explaining why patient needs cannot be met by an equivalent device on the market

Health institutions must be able to demonstrate that the exemption is used only where necessary and in the best interest of patient care.

Quality, Safety, and Governance Expectations

The guidance emphasises that health institutions using the exemption must still ensure:

• The device meets general safety and performance requirements

• Risks are identified, evaluated, and controlled

• Manufacturing processes are documented and controlled

• Staff involved are appropriately trained

The Leading practice guidelines further explain how institutions should structure governance, oversight, and documentation to demonstrate compliance.

Illustrative Examples: How the Exemption Works in Practice

To help institutions understand the boundaries of the exemption, MHRA provides illustrative examples.

These examples show:

• Situations where in-house manufacturing is justified due to patient-specific needs

• Scenarios where the exemption does not apply, such as routine manufacturing that could be met by commercial devices

• The importance of documenting decision-making and clinical rationale

The examples make clear that the exemption is not a substitute for commercial manufacturing, but a narrowly defined option for exceptional circumstances.

Understanding where each pathway applies—and where it does not—is essential for manufacturers, healthcare institutions, and regulatory professionals working within the UK medical device landscape.

For full details, readers should refer directly to the official guidance pages linked below

• Medical devices: legal requirements for specific medical products, and

• Health Institution Exemption for general medical devices.