Medical devices: placing on the GB market

Device classification

Medical devices are classified into four risk-based classes. The classification determines your conformity assessment route and the level of regulatory scrutiny. Classification rules in Part II of the Regulations are based on the device's intended purpose, invasiveness, duration of contact with the body, and whether it is active or non-active.

Class I (lowest risk): Non-invasive devices such as bandages, wheelchairs, stethoscopes, and hospital beds. Sub-categories exist for Class I sterile and Class I with a measuring function, which require additional Approved Body involvement.

Class IIa (low-medium risk): Short-term invasive devices, diagnostic equipment, and hearing aids. Requires UK Approved Body verification of technical documentation or quality system audit.

Class IIb (medium-high risk): Long-term implantable devices (excluding Class III), ventilators, and blood bags. Requires EU type-examination or full quality assurance system audit by a UK Approved Body.

Class III (highest risk): Devices that contact the heart or central nervous system, contain medicinal substances, or are manufactured using animal tissues. Requires full design examination and quality system assessment by a UK Approved Body. This is the most rigorous assessment route.

UKCA marking and CE marking transition

The GB route to market for medical devices is based on the legacy EU Directive requirements (MDD 93/42/EEC, AIMDD 90/385/EEC, IVDD 98/79/EC), not the newer EU Medical Devices Regulation 2017/745 (EU MDR).

Current marking options:

• UKCA marking via a UK Approved Body designated by MHRA is available now and has no expiry date on the GB market
• CE marking under the old EU MDD or AIMDD with a valid certificate is accepted on the GB market until 30 June 2028
• CE marking under the old EU IVDD with a valid certificate is accepted on the GB market until 30 June 2030
• CE marking under the new EU MDR or IVDR with a valid certificate is accepted on the GB market until 30 June 2030
• Class I devices self-declared under EU MDR are accepted until 30 June 2030

MHRA consultation (February 2026): MHRA has launched a consultation on potentially extending CE marking recognition for medical devices indefinitely, beyond the current 2028/2030 deadlines. Check GOV.UK for the outcome of this consultation.

Future regulatory framework: MHRA is developing a new UK regulatory framework for medical devices expected to be introduced through future legislation. This will replace the current Directive-based requirements.

MHRA registration and essential requirements

MHRA registration: All medical devices placed on the GB market must be registered with MHRA, regardless of whether they bear UKCA or CE marking. Since 1 April 2026, the registration fee is £300 per year per GMDN Level 2 category (or Level 1 where no Level 2 exists), replacing the previous £261 one-off fee.

UK Responsible Person: Non-UK manufacturers must appoint a UK Responsible Person before placing devices on the GB market. The UK Responsible Person acts on the manufacturer's behalf for MHRA registration and regulatory correspondence.

Essential requirements: Devices must satisfy the essential requirements set out in the applicable Part of the Regulations. These cover safety and performance, including design, construction, materials biocompatibility, sterility (where applicable), and information supplied with the device (labelling and instructions for use in English).

Clinical evidence: Devices must be supported by sufficient clinical evidence demonstrating conformity with the essential requirements relating to safety and performance. Clinical evidence is based on clinical data, which may include clinical investigations, published literature, and clinical experience.

Post-market surveillance and Unique Device Identification

Post-market surveillance: Manufacturers must establish and maintain a post-market surveillance system proportionate to the device class. This includes monitoring device performance once on the market and reporting serious incidents to MHRA through the vigilance system. Manufacturers must also track and investigate complaints and take corrective action where necessary.

Vigilance reporting: Serious incidents involving a medical device (death, serious deterioration in health, or a public health threat) must be reported to MHRA. Field safety corrective actions (recalls, modifications, warnings) must also be notified.

Unique Device Identification (UDI): MHRA is implementing a UDI system to improve device traceability. UDI assigns a unique identifier to each device model, enabling faster identification in safety alerts and recalls. Check MHRA guidance for the current UDI implementation timeline by device class.