| Guvnor

Enforced by: MHRA
Status: Amended (in force with amendments)
Penalty ceiling: Imprisonment 45 of 64 obligations carry imprisonment (51 weeks). 19 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer31 Any Person20 Conformity Assessment Body2 Trader1

Plus 10 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.

Manufacturer — also bound by 502 other Acts

Pressure Equipment (Safety) Regulations 2016 93 duties

Measuring Instruments Regulations 2016 85 duties

Non-Automatic Weighing Instruments Regulations 2016 78 duties

Commission Delegated Regulation (EU) 2017/654 of 19 December 2016 supplementing Regulation (EU) 2016/1628 of the European Parliament and of the Council with regard to technical and general requirements relating to emission limits and type-approval for internal combustion engines for non-road mobile machinery 76 duties

Human Medicines Regulations 2012 75 duties

Any Person — also bound by 2340 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

Conformity Assessment Body — also bound by 47 other Acts

Pressure Equipment (Safety) Regulations 2016 29 duties

Lifts Regulations 2016 28 duties

Radio Equipment Regulations 2017 27 duties

Explosives Regulations 2014 22 duties

Pyrotechnic Articles (Safety) Regulations 2015 22 duties

Trader — also bound by 825 other Acts

Value Added Tax Regulations 1995 416 duties

Companies Act 2006 243 duties

The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 133 duties

Companies Act 1985 85 duties

Insolvency (England and Wales) Rules 2016 62 duties

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.

Part 1

Introductory Provisions Relating to all Medical Devices

0 of 22 sections shown

22 other sections in this Part — procedural and definitional

s.001 Citation and commencement

s.002 Interpretation

s.003 Scope of these Regulations

s.004 Transitional provisions

s.confidentiality Confidentiality

s.designated standard Designated standard

s.expiry of certain provisions in these regulations Expiry of certain provisions in these Regulations

s.medical devices which are qualifying northern irel Medical devices which are qualifying Northern Ireland goods

s.references in other legislation to directives 90/3 References in other legislation to Directives 90/385, 93/42 and 98/79

s.revocation of commission decision 2002/364 on 26th Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date

s.revocation of commission decision 2010/227 Revocation of Commission Decision 2010/227

s.revocation of commission regulation (eu) no 207/20 Revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025

s.revocation of regulation (eu) 2017/745 Revocation of Regulation (EU) 2017/745

s.revocation of regulation (eu) 2017/746 Revocation of Regulation (EU) 2017/746

s.revocation of regulation (eu) no 2017/2185 and sav Revocation of Regulation (EU) No 2017/2185 and saving provision

s.revocation of regulation (eu) no 722/2012 on 26th Revocation of Regulation (EU) No 722/2012 on 26th May 2025

s.revocation of regulation (eu) no 920/2013 on 26th Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date

s.revocations, transitional and saving provisions in Revocations, transitional and saving provisions in respect of the new national registration requirements

s.revocation, transitional and saving provisions in Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

s.schedules Schedules

s.the classification criteria in directives 2003/12 The classification criteria in Directives 2003/12 and 2005/50

s.transitional provisions for hip, knee and shoulder Transitional provisions for hip, knee and shoulder replacements

Part 2

General Medical Devices

12 of 20 sections shown

s.007 Registration of persons placing general medical devices on the market Imprisonment

s.008 Essential requirements for general medical devices Imprisonment

Ensure medical devices meet essential safety and performance requirementsAny Person

s.009 Determining compliance of general medical devices with relevant essential requirements Imprisonment

Ensure medical device labeling and instructions are in EnglishManufacturer

s.010 UK(NI) indication: general medical devices Imprisonment

Affix UK(NI) indication to medical devices for the Northern Ireland marketManufacturer

s.010 UK marking of general medical devices Imprisonment

Apply UK marking to general medical devicesAny Person

s.011 UK marking of general medical devices that come within the scope of this Part and other legislation Imprisonment

Ensure devices meet all applicable safety laws before UK markingAny Person

s.013 Procedures for affixing a UK marking to general medical devices Imprisonment

Follow conformity procedures for UK marking of medical devicesManufacturer

s.015 Procedures for custom-made general medical devices Imprisonment

Comply with safety and documentation rules for custom-made medical devicesManufacturer

s.016 Procedures for general medical devices for clinical investigations Imprisonment

Notify MHRA before starting a medical device clinical investigationManufacturer

s.017 Manufacturers etc. and conformity assessment procedures for general medical devices Regulated

Observe manufacturer obligations in conformity assessment proceduresManufacturer

s.018 Approved bodies and the conformity assessment procedures for general medical devices Imprisonment

Other duties (1) — Crown / regulator

Approved bodies must follow specific assessment and timing rulesStatutory regulator

s.019 Registration of persons placing general medical devices on the market Regulated

8 other sections in this Part — procedural and definitional

s.005 Interpretation of Part II

s.006 Scope of Part II

s.007 Classification of general medical devices

s.012 Exemptions from regulations 8 and 10

s.014 Procedures for systems and procedure packs, and for devices to be sterilised before use

s.additional requirements relating to use of animal Additional requirements relating to use of animal tissues

s.obligations in part ii and iii of these regulation Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745

s.obligations in part ii of these regulations which Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42

Part 3

Active Implantable Medical Devices

10 of 17 sections shown

s.021 Registration of persons placing active implantable medical devices on the market Imprisonment

s.022 Essential requirements for active implantable medical devices Imprisonment

Ensure active implantable medical devices meet essential requirementsAny Person

s.024 UK(NI) indication: active implantable medical devices Imprisonment

Affix UK(NI) mark to active implantable medical devices for Northern IrelandManufacturer

s.024 UK marking of active implantable medical devices Imprisonment

Apply UK marking to active implantable medical devicesAny Person

s.025 UK marking of active implantable medical devices that come within the scope of this Part and other legislation Imprisonment

Check all applicable safety laws before UK marking medical devicesAny Person

s.027 Procedures for affixing a UK marking to active implantable medical devices Imprisonment

Check conformity before affixing UK marking to active implantable devicesManufacturer

s.028 Procedures for custom-made active implantable medical devices Imprisonment

Follow safety procedures for custom-made implantable medical devicesManufacturer

s.029 Procedures for active implantable medical devices for clinical investigations Imprisonment

Notify MHRA before starting clinical investigations of implantable devicesManufacturer

s.030 Manufacturers etc. and conformity assessment procedures for active implantable medical devices Imprisonment

Follow assessment procedures for active implantable medical devicesManufacturer

s.031 Approved bodies and the conformity assessment procedures for active implantable medical devices Imprisonment

Other duties (1) — Crown / regulator

Approved bodies must follow specific assessment rules for implantable devicesStatutory regulator

7 other sections in this Part — procedural and definitional

s.020 Interpretation of Part III

s.021 Registration of persons placing active implantable medical devices on the market

s.021 Scope of Part III

s.023 Determining compliance of active implantable medical devices with relevant essential requirements

s.026 Exemptions from regulations 22 and 24

s.obligations in part iii which are met by complying Obligations in Part III which are met by complying with obligations in Directive 90/385

s.requirement to appoint a uk responsible person for Requirement to appoint a UK responsible person for active implantable medical devices

Part 4

Post-market surveillance requirements

13 of 16 sections shown

s.044 Post-market surveillance system Imprisonment

Establish and maintain a medical device post-market surveillance systemManufacturer

s.044 Post-market surveillance plan Imprisonment

Create and maintain a post-market surveillance (PMS) planManufacturer

s.044 Preventive and corrective actions Imprisonment

Take corrective action and notify authorities if a medical device is unsafeManufacturer

s.044 Field safety corrective actions and field safety notices Imprisonment

Follow safety procedures for field safety corrective actions (FSCA)Manufacturer

s.044 Field safety corrective actions outside Great Britain Imprisonment

Report safety actions taken outside the UK to the MHRAManufacturer

s.044 Trend reporting Imprisonment

Report significant increases in device incidents (Trend Reporting)Manufacturer

s.044 Reports received by the Secretary of State Imprisonment

Review and report on medical device incidents notified by the MHRAManufacturer

s.044 Retention of post-market surveillance documentation Imprisonment

Retain post-market surveillance records for medical devicesManufacturer

s.analysis of information received under part 4a Analysis of information received under Part 4A Regulated

Investigate and report on device safety concerns flagged by the Secretary of StateManufacturer

s.initial reporting of serious incidents Initial reporting of serious incidents Regulated

Report serious incidents involving your medical devices to the MHRAManufacturer

s.investigation and final reporting of serious incid Investigation and final reporting of serious incidents Regulated

Investigate serious device incidents and submit a final reportManufacturer

s.periodic safety update report Periodic safety update report Regulated

Produce and submit periodic safety update reports for medical devicesManufacturer

s.post-market surveillance report Post-market surveillance report Regulated

Produce post-market surveillance reports for certain medical devicesManufacturer

3 other sections in this Part — procedural and definitional

s.interpretation of part 4a Interpretation of Part 4A

s.requests for post-market surveillance documentatio Requests for post-market surveillance documentation

s.scope of part 4a Scope of Part 4A

Part 4

In Vitro Diagnostic Medical Devices

10 of 25 sections shown

s.034 Essential requirements for in vitro diagnostic medical devices Imprisonment

Ensure IVD medical devices meet 'essential requirements' before supplyAny Person

s.036 UK(NI) indication: in vitro diagnostic medical devices Imprisonment

Affix UK(NI) indication to in vitro diagnostic devices for Northern IrelandManufacturer

s.036 UK marking of in vitro diagnostic medical devices Imprisonment

Apply UK marking to in vitro diagnostic medical devicesAny Person

s.037 UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation Imprisonment

Ensure devices meet all applicable health and safety laws before UK markingAny Person

s.038 Performance requirements for coronavirus test devices Imprisonment

Ensure coronavirus test devices meet sensitivity and specificity standardsManufacturer

s.038 Register of approved coronavirus test devices Regulated

Other duties (1) — Crown / regulator

Secretary of State must maintain and publish a Covid test device registerCrown / Minister / Government department

s.038 In vitro diagnostic medical devices not ready for use Imprisonment

Do not supply or use in vitro diagnostic devices that are not ready for useAny Person

s.040 Procedures for affixing a UK marking to in vitro diagnostic medical devices Imprisonment

Follow correct procedures to apply UK marking to IVD medical devicesManufacturer

s.042 Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices Imprisonment

Other duties (1) — Crown / regulator

Approved bodies must follow strict rules for IVD device assessmentsStatutory regulator

s.043 Devices for performance evaluation Imprisonment

Compile and retain documentation for performance evaluation devicesManufacturer

15 other sections in this Part — procedural and definitional

s.032 Interpretation of Part IV

s.033 Scope of Part IV

s.035 Determining compliance of in vitro diagnostic medical devices with relevant essential requirements

s.039 Exemptions from this Part

s.041 Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices

s.044 Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation

s.applications for approval of coronavirus test devi Applications for approval of coronavirus test devices

s.approval requirement for coronavirus test devices Approval requirement for coronavirus test devices

s.exemption for coronavirus test devices in conformi Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107

s.exemptions for coronavirus test devices Exemptions for coronavirus test devices

s.obligations in part iv of these regulations which Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746

s.obligations in part iv which are met by complying Obligations in Part IV which are met by complying with obligations in Directive 98/79

s.public sector use of coronavirus test devices Public sector use of coronavirus test devices

s.registration etc. of persons placing in vitro diag Registration etc. of persons placing in vitro diagnostic medical devices on the market

s.transitional provisions for coronavirus test devic Transitional provisions for coronavirus test devices

Part 5

Approved Bodies, Conformity Assessment Bodies and Marking of Products

7 of 10 sections shown

s.045 Designation etc. of approved bodies Regulated

Other duties (1) — Crown / regulator

Secretary of State must designate and oversee approved bodies for medical devicesCrown / Minister / Government department

s.046 Choice of approved bodies and conformity assessment bodies Imprisonment

Select an approved body for conformity assessmentManufacturer

s.047 Register of approved bodies Regulated

Other duties (1) — Crown / regulator

Secretary of State must maintain a public register of approved bodiesCrown / Minister / Government department

s.047 General matters relating to approved bodies Regulated

Provide conformity assessment information in EnglishManufacturer

s.049 Fees charged by approved bodies and conformity assessment bodies Regulated

Approved bodies and CABs must limit fees to reasonable costsConformity Assessment Body

s.050 Products incorrectly marked with an approved body or conformity assessment body number Imprisonment

Do not use unauthorized body numbers on medical devicesAny Person

s.051 Products incorrectly marked with a UK marking Imprisonment

Do not use medical device markings on non-medical productsAny Person

3 other sections in this Part — procedural and definitional

s.048 Designation etc. of ... conformity assessment bodies

s.interpretation of part v Interpretation of Part V

s.meaning of approved body and uk notified body Meaning of approved body and UK notified body

Part 6

Fees charged by the Secretary of State

9 of 13 sections shown

s.053 Fees in connection with the registration of devices and changes to registration details Regulated

Pay a fee when registering medical devices or updating registration detailsAny Person

s.054 Fees payable in connection with the designation of approved bodies Imprisonment

Pay required fees for medical device 'approved body' statusAny Person

s.055 Fees payable in connection with the designation etc. of ... conformity assessment bodies Imprisonment

Pay required fees for CAB designation, variations, and inspectionsAny Person

s.056 Fees in connection with approval of coronavirus test devices Imprisonment

Pay required fees for coronavirus test device approvalAny Person

s.056 Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device Imprisonment

Other duties (1) — Crown / regulator

Secretary of State must charge fees for medicinal substance consultationsCrown / Minister / Government department

s.056 Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device Regulated

Pay consultation fees for medical devices containing medicinal substancesConformity Assessment Body

s.056 Fees payable in connection with regulatory advice meetings Imprisonment

Pay fee for regulatory advice meetings with the MHRAAny Person

s.056 Fees payable in relation to clinical investigation notices Regulated

Pay required fees for clinical investigation noticesAny Person

s.058 Time for payment of fees - small companies Regulated

Pay medical device fees in instalments if you are a small companyTrader

4 other sections in this Part — procedural and definitional

s.052 Interpretation of Part VI

s.057 Unpaid fees

s.058 Waivers, reductions and refunds

s.fees payable in connection with pre-consultation m Fees payable in connection with pre-consultation meetings

Part 7

General, Enforcement and Miscellaneous

3 of 9 sections shown

s.061 Enforcement etc. Regulated

Other duties (1) — Crown / regulator

MHRA and local authorities must enforce medical device regulationsCrown / Minister / Government department

s.065 Centralised systems of records etc. Regulated

Other duties (1) — Crown / regulator

Secretary of State must maintain centralized medical device recordsCrown / Minister / Government department

s.067 Review Regulated

Other duties (1) — Crown / regulator

Secretary of State must review and report on Medical Devices RegulationsCrown / Minister / Government department

6 other sections in this Part — procedural and definitional

s.059 Interpretation of Part VII

s.060 Status of UK responsible person

s.062 Compliance notices

s.063 Restriction notices

s.064 Notification of decisions etc.

s.066 Revocations

Schedules

0 of 42 shown

42 other schedules

s.002 MUTUAL RECOGNITION AGREEMENTS

s.sch001 The Agreement establishing an Association between the European Economic Community...

s.sch002 The agreement on mutual recognition in relation to conformity assessment...

s.sch002 The agreement on mutual recognition between the European Community and...

s.sch002 The agreement between the European Community and the Swiss Confederation...

s.sch002a Modification of Annexes to Directives 90/385, 93/42, 98/79

s.sch002a (1) The Annexes to Directive 90/385 are modified so that...

s.sch002a Omit Annex 9.

s.sch002a (1) The Annexes to Directive 93/42 are modified so that...

s.sch002a In Annex I— (a) in Section 3, for “Article 1(2)(a)”...

s.sch002a In Annex II— (a) in the title omit “EC”;

s.sch002a In Annex III— (a) for each reference to “EC type-examination”...

s.sch002a In Annex IV— (a) omit “EC” (including in the title)...

s.sch002a In Annex V— (a) for “notified body” each time it...

s.sch002a In Annex VI— (a) omit “EC” each time it occurs...

s.sch002a In Annex VII— (a) in the title and in Section...

s.sch002a In Annex VIII— (a) in Section 1, for “authorized representative”...

s.sch002a In Annex 1— (za) in Section 2, for “the functions...

s.sch002a In Annex IX for “this Directive” each time it occurs...

s.sch002a In Annex X— (a) in Section 1.1 for “harmonised standards”...

s.sch002a In Annex X1— (a) in the title, for “notified bodies”...

s.sch002a Omit Annex XII.

s.sch002a (1) The Annexes to Directive 98/79 are modified so that...

s.sch002a In Annex 1— (a) in Section 3 in part A,...

s.sch002a In Annex III— (a) in the title and in Section...

s.sch002a In Annex IV— (a) in the title, omit “EC”;

s.sch002a In Annex V— (a) in the title, omit “EC” ;...

s.sch002a In Annex VI— (a) in the title omit “EC”;

s.sch002a In Annex 2— (a) for the heading substitute “Declaration of...

s.sch002a In Annex VII— (a) in the title and in Section...

s.sch002a In Annex VIII— (a) in Section 1—

s.sch002a In Annex IX— (a) in the title, for “notified bodies”...

s.sch002a Omit Annex X.

s.sch002a In Annex 3— (a) in the title for “EC TYPE-EXAMINATION”...

s.sch002a For Annex 4 substitute— ANNEX 4 VERIFICATION Verification is the procedure whereby the manufacturer ensures and declares...

s.sch002a For Annex 5, substitute— ANNEX 5 DECLARATION OF CONFORMITY TO...

s.sch002a In Annex 6— (a) in Section 1, for “authorised representative...

s.sch002a In Annex 7— (a) in Section 1.1 for “harmonised” substitute...

s.sch002a In Annex 8— (a) in the title for “when designating...

s.sch002n Mutual Recognition Agreement countries

1 other provision

s.para.139 — Australia — New Zealand — Canada — The United...

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