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The Medical Devices (Northern Ireland Protocol) Regulations 2021

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  1. Introductory Text

  2. PART 1 Preliminary

    1. 1.Citation and commencement

    2. 2.Extent and application

    3. 3.Interpretation

    4. 4.Scope

  3. PART 2 Making available on the market and putting into service under Regulation (EU) 2017/745

    1. 5.Reprocessing of single-use devices

    2. 6.Requirement on health institutions to provide information relating to implanted devices

    3. 7.Registration of custom-made devices

    4. 8.Certificates of free sale under Regulation (EU) 2017/745 - fee

    5. 9.Retention of documentation relating to conformity assessments and custom-made devices

    6. 10.UK(NI) indication under Regulation (EU) 2017/745

  4. Part 2A Making available on the market and putting into service under Regulation (EU) 2017/746

    1. 10A.Certificates of free sale under Regulation (EU) 2017/746 – fee

    2. 10B.Retention of documentation relating to conformity assessments

    3. 10C.UK(NI) indication under Regulation (EU) 2017/746

  5. PART 3 Clinical investigations under Regulation (EU) 2017/745

    1. A11.Legal representatives and contact persons for clinical investigations

    2. 11.Ethical review of clinical investigations

    3. 12.Prior authorisation of clinical investigations by the Secretary of State

    4. 13.Arbitration following the refusal of a clinical investigation application

    5. 14.Damage compensation in relation to clinical investigations

    6. 15.Retention of documentation relating to clinical investigations

    7. 16.Clinical investigation fees

    8. 17.Clinical investigations not carried out for a purpose specified in Article 62(1)

    9. 17A.Advice in relation to intended clinical investigations

  6. Part 3A Performance studies under Regulation (EU) 2017/746

    1. 17B.Legal representatives and contact persons for performance studies

    2. 17C.Ethical review of performance studies

    3. 17D.Arbitration following the refusal of a performance study application

    4. 17E.Damage compensation in relation to performance studies

    5. 17F.Retention of documentation relating to performance studies

  7. PART 4 Notified bodies designated under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

    1. 18.Notified bodies

    2. 19.Fees payable in connection with the designation of notified bodies

  8. Part 4A Fees for consultation in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device

    1. 19A.Interpretation of Part 4A

    2. 19B.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

    3. 19C.Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device

    4. 19D.Fees for pre-consultation meetings

  9. PART 5 General provision about language requirements and fees

    1. 20.Language requirements

    2. 21.Unpaid fees

    3. 22.Waivers, reductions and refunds

  10. PART 6 Enforcement

    1. 23.Offence of breaching certain provisions

    2. 24.Defence of due diligence

    3. 25.Offences by bodies corporate

    4. 26.Enforcement

  11. PART 7 Amendment of primary legislation

    1. 27.Investigatory powers under the Consumer Rights Act 2015

    2. 28.Amendment of the Medicines and Medical Devices Act 2021

  12. PART 8 Amendment of the Medical Devices Regulations 2002

    1. 29.Amendments to the Medical Devices Regulations 2002

    2. 30.Amendment of regulation 2 (interpretation)

    3. 31.Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods)

    4. 32.Revocation and transitional provision

    5. 33.Amendment of regulation 10A (UK(NI) indication: general medical devices)

    6. 34.Amendment of regulation 19 (registration of persons placing general medical devices on the market)

    7. 35.Amendment of regulation 21B (registration of persons placing active implantable medical devices on the market)

    8. 36.Amendment of regulation 24A (UK(NI) indication: active implantable medical devices)

    9. 37.Amendment of regulation 36A (UK(NI) indication: in vitro diagnostic medical devices)

  13. PART 9 Amendments of other secondary legislation

    1. 38.Amendment of the Blood Safety and Quality Regulations 2005

    2. 39.Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007

    3. 40.Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 2007

    4. 41.Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

    5. 42.Amendment of the Economic Growth (Regulatory Functions) Order 2017

    6. 43.Amendment of the Market Surveillance (Northern Ireland) Regulations 2021

  14. Signature

    1. SCHEDULE 1

      Fees for clinical investigations

    2. SCHEDULE 2

      Fees in connection with the designation of notified bodies

    3. SCHEDULE 3

      Provisions breach of which is an offence under regulation 23

  16. Explanatory Note

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