Search Legislation

Medicines and Medical Devices Act 2021

Changes to legislation:

There are currently no known outstanding effects for the Medicines and Medical Devices Act 2021. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

  1. Introductory Text

  2. PART 1 The Commissioner for Patient Safety

    1. 1.Establishment and core duties etc

  3. PART 2 Human medicines

    1. CHAPTER 1 Regulations: general

      1. 2.Power to make regulations about human medicines

      2. 3.Manufacture, marketing and supply

      3. 4.Falsified medicines

      4. 5.Clinical trials

      5. 6.Fees, offences, powers of inspectors

      6. 7.Emergencies

    2. CHAPTER 1A Regulations: information systems

      1. 7A.Information systems

      2. 7B.Offence of disclosing information

    3. CHAPTER 2 International agreements: disclosure of information

      1. 8.Disclosure of information in accordance with international agreements

    4. CHAPTER 3 Interpretation

      1. 9.Interpretation of Part 2

  4. PART 3 Veterinary medicines

    1. CHAPTER 1 Regulations

      1. 10.Power to make regulations about veterinary medicines

      2. 11.Manufacture, marketing, supply and field trials

      3. 12.Fees, offences, powers of inspectors, costs

    2. CHAPTER 2 International agreements: disclosure of information

      1. 13.Disclosure of information in accordance with international agreements

    3. CHAPTER 3 Interpretation etc

      1. 14.Interpretation of Part 3 and supplementary provision

  5. PART 4 Medical devices

    1. CHAPTER 1 Regulations: general

      1. 15.Power to make regulations about medical devices

      2. 16.Manufacture, marketing and supply

      3. 17.Fees, information, offences

      4. 18.Emergencies

    2. CHAPTER 2 Regulations: information systems, advisory committee

      1. 19.Information systems

      2. 20.Advisory committee

    3. CHAPTER 3 Enforcement

      1. Enforcement notices

        1. 21.Compliance notices

        2. 22.Suspension notices

        3. 23.Safety notices

        4. 24.Information notices

        5. 25.Applications to set notices aside etc

        6. 26.Compensation

        7. 27.Further appeals

      2. Offences

        1. 28.Offences

        2. 29.Defence of due diligence

        3. 30.Offences by bodies corporate

      3. Civil sanctions

        1. 31.Civil sanctions

      4. Forfeiture

        1. 32.Forfeiture of medical devices

        2. 33.Appeals against forfeiture decisions

      5. Recovery of expenses of enforcement

        1. 34.Recovery of expenses of enforcement

      6. Recall of medical device by enforcement authority

        1. 35.Recall of medical device by enforcement authority

      7. Power of officer of Revenue and Customs to detain medical device

        1. 36.Power of officer of Revenue and Customs to detain medical device

        2. 37.Offence of obstructing an officer of Revenue and Customs

      8. Civil proceedings

        1. 38.Civil proceedings

    4. CHAPTER 4 Disclosure of information and consequential etc provision

      1. Disclosure of information

        1. 39.Disclosure of information

        2. 40.Offences relating to information

      2. Consequential etc provision

        1. 41.Consequential and supplementary provision

    5. CHAPTER 5 Interpretation of Part 4

      1. 42.Interpretation of Part 4

  6. PART 5 Regulations under Parts 1, 2, 3 and 4

    1. 43.Power to make consequential etc provision

    2. 44.Scope of powers of Northern Ireland departments

    3. 45.Consultation

    4. 46.Reporting requirements

    5. 47.Procedure

  7. PART 6 Report on operation of medicines and medical devices legislation

    1. 48.Report on operation of medicines and medical devices legislation

  8. PART 7 Extent, commencement and short title

    1. 49.Extent

    2. 50.Commencement

    3. 51.Transitional etc provision in connection with commencement

    4. 52.Short title

  9. SCHEDULES

    1. SCHEDULE 1

      Further provision about the Commissioner for Patient Safety

      1. Principles relating to core duties

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

      2. Involvement of patients

        1. 2.(1) The Commissioner must take reasonable steps to involve patients...

      3. Supplementary functions and information

        1. 3.(1) For the purposes of carrying out the core duties,...

      4. Individual cases

        1. 4.(1) The Commissioner may not exercise functions in relation to...

      5. Amendments to primary legislation

        1. 5.(1) In Part 1 of the Table at the end...

      6. Regulations about appointment and operation

        1. 6.(1) The Secretary of State may by regulations make such...

    2. SCHEDULE 2

      Medical devices: civil sanctions

      1. PART 1 Monetary penalties

        1. Imposition of monetary penalty

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

        2. Notices, representations and appeals etc

          1. 2.(1) Where the Secretary of State proposes to impose a...

        3. Information to be included in notices under paragraph 2

          1. 3.(1) A notice under paragraph 2(1) must include information as...

        4. Monetary penalties: criminal proceedings and conviction

          1. 4.(1) Where a notice under paragraph 2(1) is served on...

      2. PART 2 Enforcement undertakings

        1. 5.(1) This paragraph applies where— (a) the Secretary of State...

      3. PART 3 Enforcement costs recovery notices

        1. Imposition of enforcement costs recovery notices

          1. 6.(1) The Secretary of State may serve an enforcement costs...

        2. Information to be included in enforcement costs recovery notices

          1. 7.(1) An enforcement costs recovery notice must specify the amount...

        3. Appeals

          1. 8.(1) A person served with an enforcement costs recovery notice...

      4. PART 4 Power to make supplementary provision etc by regulations

        1. Supplementary regulations: general

          1. 9.(1) The Secretary of State may by regulations (“supplementary regulations”)—...

        2. Monetary penalties and costs

          1. 10.(1) Supplementary regulations may make provision of any of the...

        3. Enforcement undertakings

          1. 11.Supplementary regulations may make provision of any of the following...

        4. Appeals

          1. 12.(1) Supplementary regulations may make provision of any of the...

      5. PART 5 General and supplemental

        1. Guidance as to enforcement

          1. 13.(1) The Secretary of State must prepare and publish guidance...

        2. Pre-commencement consultation

          1. 14.If, before the day on which this Schedule comes into...

        3. Reports on use of civil sanctions

          1. 15.(1) The Secretary of State must from time to time...

        4. Disclosure of information

          1. 16.(1) Information may be disclosed to the Secretary of State...

      6. PART 6 Interpretation

        1. 17.In this Schedule— “enforcement costs recovery notice” has the meaning...

    3. SCHEDULE 3

      Offence of breaching provisions in the Medical Devices Regulations 2002

      1. PART 1 Offence

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

      2. PART 2 Provisions

        1. 2.In the Medical Devices Regulations 2002 (S.I. 2002/618), after the...

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

Explanatory Notes

Text created by the government department responsible for the subject matter of the Act to explain what the Act sets out to achieve and to make the Act accessible to readers who are not legally qualified. Explanatory Notes were introduced in 1999 and accompany all Public Acts except Appropriation, Consolidated Fund, Finance and Consolidation Acts.

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources