Medical device compliance checklist

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

Medical Device Registration Fees (UKCA Marking)

MHRA fees for medical device manufacturer and device registration

Statutory registration fee (current): £261 per application
Maximum devices per application: 100 device types, 20,000 products
New fee structure (from 1 April 2026): Approximately £300 per year per Level 2 GMDN Category
Device registration requirement: All devices placed on UK market must be registered
Registration update deadline: 10 working days for any changes
Technical file retention: Minimum 10 years after last device placed on market
UK Responsible Person (UKRP): Mandatory for non-UK manufacturers
Clinical investigation fee (Class I and IIa): £15,309
Clinical investigation fee (Class IIb implantable/long-term invasive): £24,617
Clinical investigation fee (Class III and active implantable): £32,016
Clinical investigation amendment fee: £0 (no fee for amendments from 16 July 2025)
Average clinical investigation approval time: 51 calendar days

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

MHRA Penalties and Enforcement Powers

Penalties for non-compliance with medicines and medical devices regulations, distinguishing between medicines offences and device offences.

MHRA uses a graduated enforcement approach from informal advice through warning letters and statutory notices to criminal prosecution. The Medicines and Medical Devices Act 2021 introduced modern enforcement tools including civil monetary penalties as an alternative to prosecution.

MEDICAL DEVICES: Breach of UK MDR or enforcement notice: Up to 6 months imprisonment and/or unlimited fine
MEDICAL DEVICES: Civil monetary penalty (alternative to prosecution): Variable amount set by MHRA under MMD Act 2021, Section 31
MEDICAL DEVICES: Supplying falsified medical device: Up to 2 years imprisonment and/or unlimited fine (Consumer Protection Act 1987)
MEDICINES: Manufacturing without licence: Unlimited fine + up to 2 years imprisonment
MEDICINES: Wholesale distribution without licence: Unlimited fine + up to 2 years imprisonment
MEDICINES: Falsified medicines supply: Unlimited fine + up to 10 years imprisonment
BOTH: Obstruction of MHRA inspector: Criminal offence — unlimited fine (Consumer Rights Act 2015, Schedule 5)
Enforcement escalation: Informal advice → warning letters → compliance notices (s.24) → suspension notices (s.25) → safety notices (s.26) → recall notices (s.28) → civil sanctions (s.31) → criminal prosecution

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Medical device compliance checklist

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