UK Statutory Instrument 2002 United Kingdom

Medical Devices Regulations 2002

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At a glance

Enforced by

MHRA

What's here

64 compliance obligations, 16 practical guides across 2 topics · 7 journeys

Penalty landscape

45 of 64 obligations carry imprisonment (51 weeks). 19 have no criminal penalty — flagged in the list below.

Who this Act binds

Business-side actors with duties under this Act, ranked by how often they appear.

  • Manufacturer 31
  • Any Person 20
  • Licence Holder 2
  • Trader 1

Plus 10 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.

Step-by-step journeys using this legislation

Walkthroughs that take you from a real business situation to compliance.

Relevant guidance

Practical guides for businesses affected by this Act, ordered by how closely they engage with it.

Direct — cites this Act

11 guides

Supporting — topic alignment

2 guides

Mentioned in related content

3 guides
View all 16 guides →

Other Acts binding the same actors

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 472 other Acts (top 5 shown)
Any Person also bound by 2338 other Acts (top 5 shown)
Licence Holders also bound by 221 other Acts (top 5 shown)
Traders also bound by 826 other Acts (top 5 shown)

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 22 other sections in this Part — procedural / definitional / commencement
s.002

Interpretation

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.007

Registration of persons placing general medical devices on the market

51 weeks imprisonment
  • Register with the MHRA before placing medical devices on the market Any Person
s.010

UK(NI) indication: general medical devices

51 weeks imprisonment
  • Affix UK(NI) indication to medical devices for the Northern Ireland market Manufacturer
Browse 8 other sections in this Part — procedural / definitional / commencement
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.021

Registration of persons placing active implantable medical devices on the market

51 weeks imprisonment
  • Register with the MHRA before selling active implantable medical devices Any Person
s.024

UK(NI) indication: active implantable medical devices

51 weeks imprisonment
  • Affix UK(NI) mark to active implantable medical devices for Northern Ireland Manufacturer
Browse 7 other sections in this Part — procedural / definitional / commencement
s.021

Registration of persons placing active implantable medical devices on the market

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.044

Post-market surveillance system

51 weeks imprisonment
  • Establish and maintain a medical device post-market surveillance system Manufacturer
s.044

Post-market surveillance plan

51 weeks imprisonment
  • Create and maintain a post-market surveillance (PMS) plan Manufacturer
s.044

Preventive and corrective actions

51 weeks imprisonment
  • Take corrective action and notify authorities if a medical device is unsafe Manufacturer
s.044

Field safety corrective actions and field safety notices

51 weeks imprisonment
  • Follow safety procedures for field safety corrective actions (FSCA) Manufacturer
s.044

Field safety corrective actions outside Great Britain

51 weeks imprisonment
  • Report safety actions taken outside the UK to the MHRA Manufacturer
s.044

Trend reporting

51 weeks imprisonment
  • Report significant increases in device incidents (Trend Reporting) Manufacturer
s.044

Reports received by the Secretary of State

51 weeks imprisonment
  • Review and report on medical device incidents notified by the MHRA Manufacturer
s.044

Retention of post-market surveillance documentation

51 weeks imprisonment
  • Retain post-market surveillance records for medical devices Manufacturer
s.analysis of information received under part 4a

Analysis of information received under Part 4A

  • Investigate and report on device safety concerns flagged by the Secretary of State Manufacturer
s.initial reporting of serious incidents

Initial reporting of serious incidents

  • Report serious incidents involving your medical devices to the MHRA Manufacturer
s.investigation and final reporting of serious incid

Investigation and final reporting of serious incidents

  • Investigate serious device incidents and submit a final report Manufacturer
s.periodic safety update report

Periodic safety update report

  • Produce and submit periodic safety update reports for medical devices Manufacturer
s.post-market surveillance report

Post-market surveillance report

  • Produce post-market surveillance reports for certain medical devices Manufacturer
Browse 3 other sections in this Part — procedural / definitional / commencement
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 IV — In Vitro Diagnostic Medical Devices

s.036

UK(NI) indication: in vitro diagnostic medical devices

51 weeks imprisonment
  • Affix UK(NI) indication to in vitro diagnostic devices for Northern Ireland Manufacturer
s.038

Performance requirements for coronavirus test devices

51 weeks imprisonment
  • Ensure coronavirus test devices meet sensitivity and specificity standards Manufacturer
s.038

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
Browse 15 other sections in this Part — procedural / definitional / commencement
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

s.045

Designation etc. of approved bodies

Other duties (1) — Crown / regulator
  • Secretary of State must designate and oversee approved bodies for medical devices Crown / Minister / Government department
s.047

Register of approved bodies

Other duties (1) — Crown / regulator
  • Secretary of State must maintain a public register of approved bodies Crown / Minister / Government department
Browse 3 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.056

Fees in connection with approval of coronavirus test devices

51 weeks imprisonment
  • Pay required fees for coronavirus test device approval Any 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

51 weeks imprisonment
Other duties (1) — Crown / regulator
  • Secretary of State must charge fees for medicinal substance consultations Crown / 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

  • Pay consultation fees for medical devices containing medicinal substances Licence Holder
s.056

Fees payable in connection with regulatory advice meetings

51 weeks imprisonment
  • Pay fee for regulatory advice meetings with the MHRA Any Person
s.058

Time for payment of fees - small companies

  • Pay medical device fees in instalments if you are a small company Trader
Browse 4 other sections in this Part — procedural / definitional / commencement
s.fees payable in connection with pre-consultation m

Fees payable in connection with pre-consultation meetings

Part VII — General, Enforcement and Miscellaneous

s.061

Enforcement etc.

Other duties (1) — Crown / regulator
  • MHRA and local authorities must enforce medical device regulations Crown / Minister / Government department
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
s.067

Review

Other duties (1) — Crown / regulator
  • Secretary of State must review and report on Medical Devices Regulations Crown / Minister / Government department
Browse 6 other sections in this Part — procedural / definitional / commencement

Schedules

Browse 42 other Schedules — structural / supplementary
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 in relation to conformity assessment...

s.sch002

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

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

Other sections — not classified into a Part

These sections sit outside the numbered Parts — usually provisions added or moved by later amendments.

Browse 1 other section
s.para.139

— Australia — New Zealand — Canada — The United...

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Official guidance

Authoritative sources published by regulators or government explaining this legislation.

Enforcement and responsible bodies

The regulators that administer or enforce this legislation.

MHRA

Medicines and Healthcare products Regulatory Agency

Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.

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Regulators

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