Law

The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024

United Kingdom · regulation

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In force since 2024-03-21, as the publisher states.

Copy read on 2026-11-10. The page it was read from

Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

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Contents: 45 provisions
  1. Title and introductory text
  2. 1 Citation and commencement
  3. 2 Extent and application
  4. 3 Amendment to the Human Tissue Act 2004
  5. 4 Amendment to the Consumer Rights Act 2015
  6. 5 Amendment to the Medicines and Medical Devices Act 2021
  7. 6 Amendment to section 21 (compliance notices)
  8. 7 Amendment to section 42 (interpretation of Part 4)
  9. 8 Amendment to the Medical Devices Regulations 2002
  10. 9 Amendment to regulation 2 (interpretation) in relation to Great Britain
  11. 10 Amendment to regulation 2 (interpretation) in relation to Northern Ireland
  12. 11 Amendment to regulation 2A (medical devices which are qualifying Northern Ireland goods)
  13. 12 Amendment to regulation 3ZA (revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745)
  14. 13 Amendment to regulation 4T (references in other legislation to Directives 90/385, 93/42 and 98/79)
  15. 14 Revocation of regulation 19B (requirement to appoint a UK responsible person for general medical devices)
  16. 15 Revocation of regulation 21C (requirement to appoint a UK responsible person for active implantable medical devices)
  17. 16 Amendment to regulation 34A (approval requirement for coronavirus test devices)
  18. 17 New regulation 34D (exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107)
  19. 18 Amendment to regulation 44 (registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation)
  20. 19 Revocation of regulation 44ZA (requirement to appoint a UK responsible person for placing in vitro diagnostic medical devices on the market or for performance evaluation)
  21. 20 Amendment to the Blood Safety and Quality Regulations 2005
  22. 21 Amendment to the Human Tissue (Quality and Safety for Human Application) Regulations 2007
  23. 22 Amendment to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007
  24. 23 Amendment to the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012
  25. 24 Amendment to the Waste Electrical and Electronic Equipment Regulations 2013
  26. 25 Amendment to the Economic Growth (Regulatory Functions) Order 2017
  27. 26 Amendment to the Market Surveillance (Northern Ireland) Regulations 2021
  28. 27 Amendment to the Medical Devices (Northern Ireland Protocol) Regulations 2021
  29. 28 Amendment to regulation 2 (extent and application)
  30. 29 Amendment to regulation 3 (interpretation)
  31. 30 Amendment to regulation 4 (scope)
  32. 31 Amendment to regulation 8 (certificates of free sale – fee)
  33. 32 Amendment to regulation 10 (UK(NI) indication)
  34. 33 New Part 2A (Making available on the market and putting into service under Regulation (EU) 2017/746)
  35. 34 New regulation A11 (legal representatives and contact persons for clinical investigations)
  36. 35 Amendment to regulation 13 (arbitration following the refusal of a clinical investigation application)
  37. 36 New Part 3A (Performance studies under Regulation (EU) 2017/746)
  38. 37 Amendment to Part 4
  39. 38 Amendment to regulation 18 (notified bodies)
  40. 39 Amendment to regulation 19 (fees payable in connection with the designation of notified bodies)
  41. 40 Amendment to regulation 20 (language requirements)
  42. 41 Amendment to regulation 23 (offence of breaching certain provisions)
  43. 42 Amendment to regulation 26 (enforcement)
  44. 43 Amendment to Schedule 2 (fees in connection with the designation of notified bodies)
  45. 44 Amendment to Schedule 3 (provisions breach of which is an offence under regulation 23)

Proposed changes to this act

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45 provisions

40 Amendment to regulation 20 (language requirements)

In regulation 20 for “provides” substitute “or Regulation (EU) 2017/746 provide”.

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41 Amendment to regulation 23 (offence of breaching certain provisions)

For regulation 23(1) substitute— (1) A person commits an offence if the person contravenes a prohibition or fails to comply with a requirement in a provision of— (a) the regulations listed in Table 1; (b) the articles of Regulation (EU) 2017/745 listed in Table 2; (c) the articles of Regulation (EU) 2017/746 listed in Table 3; in Schedule 3 to these Regulations. .

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42 Amendment to regulation 26 (enforcement)

In regulation 26— (a) in paragraph (1), for “and Regulation (EU) 2017/745” substitute “, Regulation (EU) 2017/745 and Regulation (EU) 2017/746”; (b) in paragraph (2), for “and Regulation (EU) 2017/745” substitute “, Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.

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43 Amendment to Schedule 2 (fees in connection with the designation of notified bodies)

In Schedule 2— (a) the first column (application) in Table 1 (application fees) is amended as follows— (i) at the end of entry 1 insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”; (ii) in entry 2, after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”; (iii) at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”; (iv) in entry 4— (aa) after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”; (bb) after “an Annex” insert “to Regulation (EU) 2017/745 or Regulation (EU) 2017/746”; (v) in entry 5, after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”; (b) the first column (activity) in Table 2 (fees for assessments and reviews) is amended as follows— (i) in entry 1— (aa) after “Article 39(4)” insert “of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746”; (bb) after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”; (cc) at the end insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”; (ii) at the end of entry 2 insert “of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746”; (iii) at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746”; (iv) in entry 5— (aa) after “Article 44(7)” insert “of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746”; (bb) in sub-paragraph (b), after “Regulation (EU) 2017/745” insert “, or Regulation (EU) 2017/746”.

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44 Amendment to Schedule 3 (provisions breach of which is an offence under regulation 23)

In Schedule 3— (a) for Table 1 substitute— Table 1 Regulation | Title of the regulation 5 | Reprocessing of single-use devices 6 | Requirement on health institutions relating to implanted devices 7 | Provision of information relating to custom-made devices 9 | Retention of documentation relating to conformity assessments and custom-made devices 10 | UK(NI) indication under Regulation (EU) 2017/745 10B | Retention of documentation relating to conformity assessments 10C | UK(NI) indication under Regulation (EU) 2017/746 11 | Ethical review of clinical investigations 12(1) | Prior authorisation of clinical investigations by the Secretary of State 14 | Damage compensation in relation to clinical investigations 15 | Retention of documentation relating to clinical investigations 17C | Ethical review of performance studies 17E | Damage compensation in relation to performance studies 17F | Retention of documentation relating to performance studies (b) in Table 2— (i) for “general obligations on manufacturers” substitute “general obligations of manufacturers”; (ii) for “32(1), (2)” substitute “32(1) (except the second sentence of the third sub-paragraph), (2)”; (iii) for “86” substitute “86 (except the second and third sentences of paragraph (2))”; (c) after Table 2 insert— Table 3 Article | Title of the article 5(1) to (3), (5) | Placing on the market and putting into service 6(1) to (3) | Distance sales 7 | Claims 9(3) | Common specifications 10 (except the second, third or fourth sub-paragraphs of paragraph 13) | General obligations of manufacturers 11(1), (3), (6) | Authorised representative 12 | Change of authorised representative 13 | General obligations of importers 14 | General obligations of distributors 15 | Person responsible for regulatory compliance 16(3), (4) | Cases in which obligations of manufacturers apply to importers, distributors or other persons 20(1) | Parts and components 22 | Identification within the supply chain 29(1) (except the second sentence of the third sub-paragraph), (2) | Summary of safety and performance 48(1), (2), (3) (except the third sub-paragraph), (4) (except the second sub-paragraph), (7) (except the third sub-paragraph), (8) (except the second sub-paragraph), (9) and (10) | Conformity assessment procedures 49(3) | Involvement of notified bodies in conformity assessment procedures 53(1) | Voluntary change of notified body 57 | General requirements regarding performance studies 58(1), (2), (4) (except the second sub-paragraph), (5), (6) and (8) | Additional requirements for certain performance studies 79 | Post-market surveillance plan 80 | Post-market surveillance report 81 (except the second and third sentences of paragraph (2)) | Periodic safety update report 84(1), (3) (except the first sub-paragraph), (5) and (8) | Analysis of serious incidents and field safety corrective actions 89 (only the final paragraph) | Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance .

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