- Enforced by
- MHRA
- Status
- In Force
- Penalty ceiling
- Imprisonment 5 of 9 obligations carry imprisonment (51 weeks). 1 carries different penalties and 3 have no criminal penalty — flagged in the list below.
Does it bind you?
Business-side roles with duties under this instrument.
Plus 2 duties on the regulator, Crown ministers and public bodies — folded into the section list below.
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Any Person — also bound by 2684 other Acts
Director or Officer — also bound by 482 other Acts
What it requires
Sections 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.
The Commissioner for Patient Safety
0 of 1 section shown1 other section in this Part — procedural and definitional
Human medicines
2 of 10 sections shownOther duties (1) — Crown / regulator
- Government may suspend medicine regulations in health emergenciesCrown / Minister / Government department
- Illegally use or disclose protected informationAny Person
8 other sections in this Part — procedural and definitional
Veterinary medicines
0 of 5 sections shown5 other sections in this Part — procedural and definitional
Medical devices
5 of 28 sections shown- Breach a compliance, suspension, safety or information noticeAny Person
- Officer liable for corporate offence under s.28Director or Officer
- Obstruct a Revenue and Customs officerAny Person
- Liability for breaching medical device regulationsAny Person
- Unauthorised use or disclosure of confidential informationAny Person
23 other sections in this Part — procedural and definitional
Regulations under Parts 1, 2, 3 and 4
1 of 5 sections shownOther duties (1) — Crown / regulator
- Medicines regulators must report on regulations every 24 monthsCrown / Minister / Government department
4 other sections in this Part — procedural and definitional
Report on operation of medicines and medical devices legislation
0 of 1 section shown1 other section in this Part — procedural and definitional
Extent, commencement and short title
0 of 4 sections shown4 other sections in this Part — procedural and definitional
Schedules
1 of 28 shown- Fail to comply with medical device regulationsAny Person
27 other schedules
Help complying
Guvnor’s practical routes through this instrument.
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.
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, …
Set up as a pharmaceutical manufacturer
Learning path for new pharmaceutical manufacturers. Work out which MHRA authorisation applies to what you make, get registered or licensed with a …
6 more guides that reference this instrument
Connected legislation
Instruments made under this Act. They carry the detail the Act delegates.
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.