Medicines and Medical Devices Act 2021

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

      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 2 International agreements: disclosure of information

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

   3. 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. 1. Principles relating to core duties

      2. 2. Involvement of patients

      3. 3. Supplementary functions and information

      4. 4. Individual cases

      5. 5. Amendments to primary legislation

      6. 6. Regulations about appointment and operation

   2. SCHEDULE 2

      Medical devices: civil sanctions

      1. PART 1 Monetary penalties

         1. 1. Imposition of monetary penalty

         2. 2. Notices, representations and appeals etc

         3. 3. Information to be included in notices under paragraph 2

         4. 4. Monetary penalties: criminal proceedings and conviction

      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. 6. Imposition of enforcement costs recovery notices

         2. 7. Information to be included in enforcement costs recovery notices

         3. 8. Appeals

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

         1. 9. Supplementary regulations: general

         2. 10. Monetary penalties and costs

         3. 11. Enforcement undertakings

         4. 12. Appeals

      5. PART 5 General and supplemental

         1. 13. Guidance as to enforcement

         2. 14. Pre-commencement consultation

         3. 15. Reports on use of civil sanctions

         4. 16. Disclosure of information

      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...