| Guvnor

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.

Any Person6 Director or Officer1

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

Human Medicines Regulations 2012 184 duties

Merchant Shipping Act 1995 144 duties

Insolvency (England and Wales) Rules 2016 104 duties

Communications Act 2003 92 duties

Road Traffic Act 1988 92 duties

Director or Officer — also bound by 482 other Acts

Insolvency (England and Wales) Rules 2016 162 duties

Companies Act 2006 126 duties

Insolvency Act 1986 77 duties

The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 68 duties

Building Societies Act 1986 32 duties

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.

Part 1

The Commissioner for Patient Safety

0 of 1 section shown

1 other section in this Part — procedural and definitional

s.001 Establishment and core duties etc

Part 2

Human medicines

2 of 10 sections shown

s.007 Emergencies Regulated

Other duties (1) — Crown / regulator

Government may suspend medicine regulations in health emergenciesCrown / Minister / Government department

s.007 Offence of disclosing information Imprisonment

Illegally use or disclose protected informationAny Person

8 other sections in this Part — procedural and definitional

s.002 Power to make regulations about human medicines

s.003 Manufacture, marketing and supply

s.004 Falsified medicines

s.005 Clinical trials

s.006 Fees, offences, powers of inspectors

s.007 Information systems

s.008 Disclosure of information in accordance with international agreements

s.009 Interpretation of Part 2

Part 3

Veterinary medicines

0 of 5 sections shown

5 other sections in this Part — procedural and definitional

s.010 Power to make regulations about veterinary medicines

s.011 Manufacture, marketing, supply and field trials

s.012 Fees, offences, powers of inspectors, costs

s.013 Disclosure of information in accordance with international agreements

s.014 Interpretation of Part 3 and supplementary provision

Part 4

Medical devices

5 of 28 sections shown

s.028 Offences Imprisonment

Breach a compliance, suspension, safety or information noticeAny Person

s.030 Offences by bodies corporate Imprisonment

Officer liable for corporate offence under s.28Director or Officer

s.037 Offence of obstructing an officer of Revenue and Customs Imprisonment

Obstruct a Revenue and Customs officerAny Person

s.038 Civil proceedings Regulated

Liability for breaching medical device regulationsAny Person

s.040 Offences relating to information Imprisonment

Unauthorised use or disclosure of confidential informationAny Person

23 other sections in this Part — procedural and definitional

s.015 Power to make regulations about medical devices

s.016 Manufacture, marketing and supply

s.017 Fees, information, offences

s.018 Emergencies

s.019 Information systems

s.020 Advisory committee

s.021 Compliance notices

s.022 Suspension notices

s.023 Safety notices

s.024 Information notices

s.025 Applications to set notices aside etc

s.026 Compensation

s.027 Further appeals

s.029 Defence of due diligence

s.031 Civil sanctions

s.032 Forfeiture of medical devices

s.033 Appeals against forfeiture decisions

s.034 Recovery of expenses of enforcement

s.035 Recall of medical device by enforcement authority

s.036 Power of officer of Revenue and Customs to detain medical device

s.039 Disclosure of information

s.041 Consequential and supplementary provision

s.042 Interpretation of Part 4

Part 5

Regulations under Parts 1, 2, 3 and 4

1 of 5 sections shown

s.046 Reporting requirements Regulated

Other 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

s.043 Power to make consequential etc provision

s.044 Scope of powers of Northern Ireland departments

s.045 Consultation

s.047 Procedure

Part 6

Report on operation of medicines and medical devices legislation

0 of 1 section shown

1 other section in this Part — procedural and definitional

s.048 Report on operation of medicines and medical devices legislation

Part 7

Extent, commencement and short title

0 of 4 sections shown

4 other sections in this Part — procedural and definitional

s.049 Extent

s.050 Commencement

s.051 Transitional etc provision in connection with commencement

s.052 Short title

Schedules

1 of 28 shown

s.sch003 Offence of breaching provisions in the Medical Devices Regulations 2002 Imprisonment

Fail to comply with medical device regulationsAny Person

27 other schedules

s.sch001 Further provision about the Commissioner for Patient Safety

s.sch001 (1) The Commissioner must prepare and publish a set of...

s.sch001 (1) The Commissioner must take reasonable steps to involve patients...

s.sch001 (1) For the purposes of carrying out the core duties,...

s.sch001 (1) The Commissioner may not exercise functions in relation to...

s.sch001 (1) In Part 1 of the Table at the end...

s.sch001 (1) The Secretary of State may by regulations make such...

s.sch002 Medical devices: civil sanctions

s.sch002 (1) The Secretary of State may impose a monetary penalty...

s.sch002 (1) Supplementary regulations may make provision of any of the...

s.sch002 Supplementary regulations may make provision of any of the following...

s.sch002 (1) Supplementary regulations may make provision of any of the...

s.sch002 (1) The Secretary of State must prepare and publish guidance...

s.sch002 If, before the day on which this Schedule comes into...

s.sch002 (1) The Secretary of State must from time to time...

s.sch002 (1) Information may be disclosed to the Secretary of State...

s.sch002 In this Schedule— “enforcement costs recovery notice” has the meaning...

s.sch002 (1) Where the Secretary of State proposes to impose a...

s.sch002 (1) A notice under paragraph 2(1) must include information as...

s.sch002 (1) Where a notice under paragraph 2(1) is served on...

s.sch002 (1) This paragraph applies where— (a) the Secretary of State...

s.sch002 (1) The Secretary of State may serve an enforcement costs...

s.sch002 (1) An enforcement costs recovery notice must specify the amount...

s.sch002 (1) A person served with an enforcement costs recovery notice...

s.sch002 (1) The Secretary of State may by regulations (“supplementary regulations”)—...

s.sch003 In the Medical Devices Regulations 2002 (S.I. 2002/618), after regulation...

s.sch003 In the Medical Devices Regulations 2002 (S.I. 2002/618), after the...

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

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, …

9 more guides that reference this instrument

AI medical device compliance Get authorised to manufacture medicines: MHRA licensing, active-substance registration and GMP Software and AI as medical devices (SaMD/AIaMD) Start a clinical laboratory service Which medicines manufacturing authorisation applies MHRA licensing for medicines and medical devices Medical device compliance checklist Report a medical device safety incident to MHRA Tech Sector Licensing and Authorisations

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.