The Medicines and Healthcare products Regulatory Agency (MHRA) publishes a register of medical devices that have been granted exceptional use authorisations — exemptions that allow manufacturers to place devices on the UK market without the standard UKCA or CE conformity assessment. Updated on 15 April 2026, the register is a reference that pharmacists handling medical devices should understand.

What exceptional use authorisations are

Under the Medical Devices Regulations 2002 (as amended), the MHRA can grant an exemption allowing a specific medical device to be placed on the UK market without a full conformity assessment. These authorisations are typically granted when:

• A device is needed urgently for patient safety and no conformity-assessed alternative is available
• A manufacturer is transitioning between regulatory frameworks (e.g. from EU CE marking to UKCA)
• A supply disruption means that an already-assessed device is temporarily unavailable and an alternative must be sourced

The authorisations are not blanket approvals. Each is specific to a named manufacturer, a named device, and a defined period. The MHRA register also records authorisations that have expired or been cancelled, providing a complete audit trail.

Why this matters for pharmacy

Community pharmacists do not typically procure medical devices directly from manufacturers — devices reach the pharmacy through wholesalers and buying groups. However, understanding exceptional use authorisations is relevant in several scenarios:

1. Blood glucose monitors and test strips

Blood glucose monitoring systems are Class IIb medical devices. If a manufacturer of a widely used glucose monitor receives an exceptional use authorisation (for example, because their UKCA marking is pending), the device remains legal to sell and supply in the UK during the authorisation period. Pharmacists who stock these devices should check that any device they supply is either UKCA/CE marked or covered by a current MHRA exceptional use authorisation.

2. Point-of-care testing devices

Pharmacies offering blood pressure monitoring, cholesterol testing or HbA1c point-of-care testing use devices that fall under medical device regulations. An exceptional use authorisation for a point-of-care device means the device has been assessed as safe for use but has not completed the full conformity process. Pharmacists should retain records of which devices they use and verify their regulatory status.

3. Wound care and compression devices

Specialist wound dressings, compression hosiery and negative-pressure wound therapy devices supplied through pharmacy are all regulated medical devices. Supply disruptions — particularly for niche or specialist products — can trigger exceptional use authorisations for alternative products.

4. Inhaler devices

Inhaler devices (as distinct from the medicine they contain) are regulated as medical devices or as combination products. Changes to inhaler device design or manufacturing may occasionally require exceptional use authorisations during transitional periods.

How to check the register

The MHRA exceptional use authorisations register is published on GOV.UK. It lists:

• The manufacturer name
• The device name and description
• The date the authorisation was granted
• Whether the authorisation is current, expired or cancelled
• Any conditions attached to the authorisation

Pharmacists who supply medical devices should check this register when they encounter an unfamiliar device or one that appears to lack standard UKCA or CE marking. The register is updated regularly and is freely accessible.

The broader regulatory context

The UK's transition from EU CE marking to the UKCA marking regime has created a transitional period during which many medical devices are supplied under bridging arrangements. The MHRA has extended recognition of CE-marked devices until 30 June 2030 for most device classes, but some manufacturers — particularly smaller firms — may need exceptional use authorisations to bridge gaps in their certification timeline.

For pharmacists, the practical implication is straightforward: a device with a valid UKCA mark, a valid CE mark (within the extended recognition period), or a current MHRA exceptional use authorisation is legal to supply in the UK. A device with none of these should not be supplied.

Where to explore further

Pharmacists can use PharmSee's pharmacy search to explore which pharmacies in their area offer enhanced services that involve medical devices, such as point-of-care testing or blood pressure monitoring. The job search tool may also surface roles with a medical devices or clinical governance focus, and salary data provides benchmarks for specialist and governance-focused pharmacy positions.

Caveats

This article provides a general overview of the MHRA exceptional use authorisations framework as it applies to community pharmacy. It does not constitute regulatory advice. Pharmacists with specific questions about the regulatory status of a medical device should consult the MHRA directly or seek advice from their responsible person or superintendent pharmacist. The MHRA register is updated regularly; the information described here reflects the register as published on 15 April 2026.

Sources

• MHRA: Medical devices given exceptional use authorisations (GOV.UK, updated 15 April 2026)
• Medical Devices Regulations 2002 (as amended)
• MHRA: Guidance on UKCA marking for medical devices
• PharmSee vacancy database, 1,715 active roles as at 15 April 2026