All MHRA guidance (by topic)
Disclaimer
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 document.
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 publication date.
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 |