Medical device compliance checklist

Guide summary

Appoint a UK Responsible Person if you are a non-UK manufacturer
Register each device with the MHRA through DORS before you place it on the market
Report serious public health threats within 2 calendar days of becoming aware
Report death or unanticipated serious deterioration in health within 10 calendar days
Report all other reportable serious incidents within 15 calendar days; the old deadline was 30 days
Send vigilance reports through the MHRA MORE portal (Medical Online Reporting Environment)
Update your MHRA registration within 10 working days of changes
Keep technical documentation for at least 10 years, or 15 years for implantables

Confirm your medical device meets all regulatory requirements for the Great Britain market. These checks cover the key obligations under the Medical Devices Regulations 2002 and the enhanced post-market surveillance requirements in force from 16 June 2025.

Medical device classification system

Risk-based classification system for medical devices determining regulatory pathway.

Class I (lowest risk): Non-invasive devices with minimal risk — self-certification by manufacturer (e.g., bandages, wheelchairs, stethoscopes)
Class Is (sterile, low risk): Sterile low-risk devices — self-certification plus UK Approved Body assessment for sterility aspects (e.g., sterile bandages, sterile surgical gloves)
Class Im (measuring, low risk): Low-risk devices with measuring function — self-certification plus UK Approved Body for metrological aspects (e.g., non-invasive thermometers, graduated syringes)
Class IIa (low-medium risk): Short-term invasive devices and diagnostic equipment — UK Approved Body assessment required (e.g., hearing aids, dental crowns, blood pressure monitors)
Class IIb (medium-high risk): Long-term invasive and surgically invasive devices — UK Approved Body full assessment required (e.g., ventilators, blood bags, condoms)
Class III (highest risk): Devices contacting heart or CNS, containing medicinal substances, or made from animal tissue — UK Approved Body full design examination and QMS assessment (e.g., heart valves, hip implants, coronary stents, pacemakers)
Active implantable medical devices (AIMD): Devices totally or partially introduced into the human body and intended to remain — UK Approved Body full assessment required (e.g., cardiac pacemakers, cochlear implants, neurostimulators)
Classification basis: Classification determined by intended purpose, invasiveness, duration of body contact, and whether device is active — rules in Annex IX of retained Directive 93/42/EEC

Medical device classification guidance (opens in a new tab)

Medical device vigilance reporting timelines

Statutory timelines for reporting serious medical device incidents to MHRA, effective 16 June 2025.

Effective date: 16 June 2025
Serious public health threat: 2 calendar days from when manufacturer becomes aware
Death or unanticipated serious deterioration in health: 10 calendar days from when manufacturer becomes aware
All other reportable serious incidents (including anticipated serious deterioration): 15 calendar days from when manufacturer becomes aware
Previous reporting deadline (replaced): 30 calendar days
Reporting portal: MHRA MORE (Medical Online Reporting Environment)
Who must report: UK Responsible Person, manufacturer, or authorised representative
Reportable serious incident definition: Death of a patient, user, or other person; serious deterioration in the state of health; or a serious public health threat
Trend reporting: Required when statistical patterns of incidents are identified
Field Safety Corrective Action (FSCA): Required when investigation identifies risk to devices already on the market (e.g. recall, modification, additional warnings)
Geographic scope: Great Britain (England, Scotland, Wales)

MHRA Vigilance Reporting Requirements (opens in a new tab)

Legal basis

Primary legislation and key regulations

Medical Devices Regulations 2002 SI 2002 · UK-wide Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 SI 2024 · UK-wide

Browse UK legislation legislation.gov.uk

Official guidance

MHRA: register medical devices to place on the market (opens in a new tab)

MHRA · Great Britain

Current MHRA fees (opens in a new tab)

Publication · MHRA · Great Britain

Vigilance reporting requirements (opens in a new tab)

Publication · MHRA · Great Britain

Medical devices - conformity assessment and the UKCA mark (opens in a new tab)

MHRA · Great Britain

Regulating medical devices in the UK (MHRA guidance) (opens in a new tab)

MHRA

Medical device compliance checklist

Legal basis

Official guidance

Related guides in General Compliance

Placing medical devices on the Northern Ireland market

Report a medical device safety incident to MHRA

MHRA authorisation for medicines and medical devices

Post-market surveillance for medical devices

Software and AI as medical devices (SaMD/AIaMD)