For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.

Manufacturers also bound by 82 other Acts (top 5 shown)

Toys (Safety) Regulations 2011 2011 27 duties
Radio Equipment Regulations 2017 2017 25 duties
Lifts Regulations 2016 2016 22 duties
Electromagnetic Compatibility Regulations 2016 2016 21 duties
Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (as amended) 2012 20 duties

Any Person also bound by 749 other Acts (top 5 shown)

Human Medicines Regulations 2012 2012 110 duties
Licensing Act 2003 2003 105 duties
Merchant Shipping Act 1995 1995 97 duties
Road Traffic Act 1988 1988 95 duties
Air Navigation Order 2016 2016 86 duties

Licence Holders also bound by 50 other Acts (top 5 shown)

Space Industry Regulations 2021 2021 50 duties
Human Medicines Regulations 2012 2012 11 duties
Value Added Tax Regulations 1995 1995 7 duties
Air Navigation Order 2016 2016 5 duties
Animal Welfare (Licensing of Activities Involving Animals) (England) Regulations 2018 2018 5 duties

Traders also bound by 219 other Acts (top 5 shown)

Value Added Tax Regulations 1995 1995 952 duties
TULRCA 1992 1992 39 duties
Companies Act 2006 2006 39 duties
Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 2013 39 duties
The Customs (Import Duty) (EU Exit) Regulations 2018 2018 33 duties

What this Act requires

Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.

Part I — Introductory Provisions Relating to all Medical Devices

Browse 20 other sections in this Part — procedural / definitional / commencement

s.001

Citation and commencement

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 II — General Medical Devices

s.registration of persons placing general medical de

Registration of persons placing general medical devices on the market

51 weeks imprisonment

s.uk(ni) indication: general medical devices

UK(NI) indication: general medical devices

51 weeks imprisonment

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

Browse 6 other sections in this Part — procedural / definitional / commencement

s.005

Interpretation of Part II

s.006

Scope of Part II

s.019

Registration of persons placing general medical devices on the market

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 III — Active Implantable Medical Devices

s.022

Essential requirements for active implantable medical devices

51 weeks imprisonment

Ensure active implantable medical devices meet essential requirements Any Person

s.registration of persons placing active implantable

Registration of persons placing active implantable medical devices on the market

51 weeks imprisonment

s.uk(ni) indication: active implantable medical devi

UK(NI) indication: active implantable medical devices

51 weeks imprisonment

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

Browse 3 other sections in this Part — procedural / definitional / commencement

s.020

Interpretation of Part III

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 4A — Post-market surveillance requirements

s.field safety corrective actions and field safety n

Field safety corrective actions and field safety notices

51 weeks imprisonment

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

s.field safety corrective actions outside great brit

Field safety corrective actions outside Great Britain

51 weeks imprisonment

Report safety actions taken outside the UK to the MHRA Manufacturer

s.post-market surveillance plan

Post-market surveillance plan

51 weeks imprisonment

Create and maintain a post-market surveillance (PMS) plan Manufacturer

s.post-market surveillance system

Post-market surveillance system

51 weeks imprisonment

Establish and maintain a medical device post-market surveillance system Manufacturer

s.preventive and corrective actions

Preventive and corrective actions

51 weeks imprisonment

Take corrective action and notify authorities if a medical device is unsafe Manufacturer

s.reports received by the secretary of state

Reports received by the Secretary of State

51 weeks imprisonment

Review and report on medical device incidents notified by the MHRA Manufacturer

s.retention of post-market surveillance documentatio

Retention of post-market surveillance documentation

51 weeks imprisonment

Retain post-market surveillance records for medical devices Manufacturer

s.trend reporting

Trend reporting

51 weeks imprisonment

Report significant increases in device incidents (Trend Reporting) Manufacturer

Browse 8 other sections in this Part — procedural / definitional / commencement

s.analysis of information received under part 4a

Analysis of information received under Part 4A

s.initial reporting of serious incidents

Initial reporting of serious incidents

s.interpretation of part 4a

Interpretation of Part 4A

s.investigation and final reporting of serious incid

Investigation and final reporting of serious incidents

s.periodic safety update report

Periodic safety update report

s.post-market surveillance report

Post-market surveillance report

s.requests for post-market surveillance documentatio

Requests for post-market surveillance documentation

s.scope of part 4a

Scope of Part 4A

Part IV — In Vitro Diagnostic Medical Devices

s.034

Essential requirements for in vitro diagnostic medical devices

51 weeks imprisonment

Ensure IVD medical devices meet 'essential requirements' before supply Any Person

s.038

In vitro diagnostic medical devices not ready for use

51 weeks imprisonment

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

s.performance requirements for coronavirus test devi

Performance requirements for coronavirus test devices

51 weeks imprisonment

Ensure coronavirus test devices meet sensitivity and specificity standards Manufacturer

s.register of approved coronavirus test devices

Register of approved coronavirus test devices

Other duties (1) — Crown / regulator

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

s.uk(ni) indication: in vitro diagnostic medical dev

UK(NI) indication: in vitro diagnostic medical devices

51 weeks imprisonment

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

Browse 11 other sections in this Part — procedural / definitional / commencement

s.033

Scope of Part IV

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 V — Approved Bodies, Conformity Assessment Bodies and Marking of Products

Browse 2 other sections in this Part — procedural / definitional / commencement

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 VI — Fees charged by the Secretary of State

s.circumstances in which a fee is payable in relatio

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

51 weeks imprisonment

Other duties (1) — Crown / regulator

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

s.fees in connection with approval of coronavirus te

Fees in connection with approval of coronavirus test devices

51 weeks imprisonment

Pay required fees for coronavirus test device approval Any Person

s.fees payable in connection with a consultation or

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

Pay consultation fees for medical devices containing medicinal substances Licence Holder

s.fees payable in connection with regulatory advice

Fees payable in connection with regulatory advice meetings

51 weeks imprisonment

Pay fee for regulatory advice meetings with the MHRA Any Person

s.time for payment of fees - small companies

Time for payment of fees - small companies

Pay medical device fees in instalments if you are a small company Trader

Browse 3 other sections in this Part — procedural / definitional / commencement

s.052

Interpretation of Part VI

s.057

Unpaid fees

s.fees payable in connection with pre-consultation m

Fees payable in connection with pre-consultation meetings

Part VII — General, Enforcement and Miscellaneous

s.065

Centralised systems of records etc.

Other duties (1) — Crown / regulator

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

Browse 5 other sections in this Part — procedural / definitional / commencement

s.059

Interpretation of Part VII

s.062

Compliance notices

s.063

Restriction notices

s.064

Notification of decisions etc.

s.066

Revocations

Schedules

Browse 3 other Schedules — structural / supplementary

s.002

MUTUAL RECOGNITION AGREEMENTS

s.sch002a

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

s.sch002n

Mutual Recognition Agreement countries

Other sections — not classified into a Part

These sections exist in the Act but the contents-of-Parts walker did not place them under a Part. Likely amendments or sections inserted out of the original Part structure.

s.008