- Enforced by
- MHRA
- Status
- In Force
- Penalty ceiling
- Regulated
Does it bind you?
Business-side roles with duties under this instrument.
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Manufacturer — also bound by 551 other Acts
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
- Maintain post-market surveillance system and comply with reporting dutiesManufacturer
5 other provisions — procedural and definitional
Help complying
Guvnor’s practical routes through this instrument.
Run a healthcare business
Ongoing compliance for CQC-registered healthcare providers covering inspections, professional registration, safeguarding, clinical governance, medicines management, and staff obligations
Respond to a medicines or controlled drugs incident
What to do when a medicines incident occurs: medication error, controlled drug discrepancy, or CD theft/loss. Covers securing the patient and evidence, …
Placing a medical device on the GB market
End-to-end learning path for manufacturers bringing a medical device to the Great Britain market for the first time. Covers pre-market steps (classification, …
Medical device compliance quick check
Quick compliance verification for experienced medical device manufacturers. Check your device classification, registration status, marking validity, PMS system, and vigilance reporting readiness.
Selling medical devices in both GB and Northern Ireland
How to achieve dual-market access for medical devices across Great Britain and Northern Ireland. Covers the different regulatory frameworks, marking options, conformity …
Responding to a medical device safety incident
Immediate actions when a serious incident occurs involving your medical device. Covers incident identification, reporting timeline determination, MORE portal submission, investigation requirements, …
Post-market surveillance for medical devices
If you place medical devices on the Great Britain market, you must run a post-market surveillance system proportionate to their risk class, …
Report a medical device safety incident to MHRA
If your medical device is involved in a serious incident in Great Britain, report it to the MHRA through the MORE portal: …
2 more guides that reference this instrument
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.