All MHRA guidance (by topic)
MHRA guidance documents are published on gov.uk and updated periodically. This index provides navigation to key guidance — always verify the current version on gov.uk before relying on any specific guidance documents by topic document, as regulations and MHRA positions evolve over time.
How to find MHRA guidance
All MHRA medical device guidance is published at: gov.uk/topic/medicines-medical-devices-blood/medical-devices
Use the filters on the MHRA publications page to narrow by topic, device type, or results publication date, other relevant criteria to locate the most current guidance applicable to your device.
Key guidance by topic
Classification and definition
| Guidance title | What it covers |
|---|---|
| Classification of medical devices | How to apply the Schedule 2 classification rules; borderline products |
| Borderline products guidance | Whether a product is a medical device, medicine, or cosmetic |
| Software and AI as a medical device | Qualification and classification of SaMD; AI/ML guidance |
Essential Requirements and conformity
| Guidance title | What it covers |
|---|---|
| Guidance on the UK MDR 2002 | MHRA's overarching guidance on the full Regulations |
| Essential Requirements for medical devices | Applying Schedule 1 ERs; designated standards |
| Conformity assessment for medical devices | Choosing conformity assessment routes; self-declaration vs UKAB |
Clinical evidence
| Guidance title | What it covers |
|---|---|
| Clinical evaluation of medical devices | Clinical evaluation methodology; MEDDEV 2.7/1 application in UK |
| Performance evaluation for IVDs | IVD performance evaluation; analytical and clinical performance |
| Clinical investigations in the UK | Notification, ethics, ISO 14155, adverse event reporting during investigations |
Registration and UKCA
| Guidance title | What it covers |
|---|---|
| Registering medical devices | MHRA registration requirements; Submissions portal guide |
| UKCA marking | How to obtain and use the UKCA mark; CE marking transitional acceptance |
| UK Responsible Persons | UKRP obligations; who can act as UKRP |
Post-market
| Guidance title | What it covers |
|---|---|
| Adverse incident reporting for medical devices | Vigilance reporting; timeframes; FSCAs; trend reporting |
| Post-market surveillance for medical devices | PMS obligations; PSUR requirements |
Device-type specific
| Guidance title | What it covers |
|---|---|
| IVD medical devices | IVD-specific requirements including Part III UK MDR 2002 |
| Active implantable medical devices | AIMD-specific requirements |
| Custom-made medical devices | Custom-made device exemption and obligations |
| Reprocessing of single-use devices | MHRA's position on reprocessed SUDs |
MHRA device alerts and safety notices
Published device alerts, field safety notices, and MHRA-issued safety communications are at: gov.uk/drug-device-alerts
Official sources
| Source | URL |
|---|---|
| MHRA medical devices hub | gov.uk/topic/medicines-medical-devices-blood/medical-devices |
| MHRA publications | gov.uk/government/publications?departments=mhra |
| MHRA Submissions portal | submissions.mhra.gov.uk |
| MHRA Yellow Card | yellowcard.mhra.gov.uk |
Under the 'Essential Requirements and conformity' section, add:
| Quality Management Systems (QMS) | QMS requirements under UK MDR 2002; ISO 13485 application; QMS audit scope and frequency |
Under the 'Post-market' section, add:
| Periodic Safety Update Reports (PSURs) | PSUR requirements by device class; content, frequency, and UKAB submission |
Under the 'Registration and UKCA' section, add:
| UK Declaration of Conformity | Content requirements; signing authority; differences from EU DoC; lifecycle maintenance |
Under the 'Post-market' section, add:
| Field Safety Corrective Actions and Notices | FSCA decision criteria; FSN content and distribution; MHRA review requirements |
Under the 'Device-type specific' section, add:
| Software as a Medical Device (SaMD) and AI/ML | Technical documentation for SaMD; AI Change Programme requirements; validation and testing |
Under the 'Registration and UKCA' section, add:
| Unique Device Identification (UDI) | UK UDI requirements; DI and PI structure; MHRA implementation timeline; relationship to EU UDI |