The Medical Devices (Northern Ireland Protocol) Regulations 2021

PART 1Preliminary

1Citation and commencement

2Extent and application

3Interpretation

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

5Reprocessing of single-use devices

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

7Registration of custom-made devices

8Certificates of free sale - fee

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

10UK(NI) indication

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

11Ethical review of clinical investigations

12Prior authorisation of clinical investigations by the Secretary of State

13Arbitration following the refusal of a clinical investigation application

14Damage compensation in relation to clinical investigations

15Retention of documentation relating to clinical investigations

16Clinical investigation fees

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

PART 4Notified bodies designated under Regulation (EU) 2017/745

18Notified bodies

19Fees payable in connection with the designation of notified bodies

PART 5General provision about language requirements and fees

20Language requirements

22Waivers, reductions and refunds

PART 6Enforcement

23Offence of breaching certain provisions

24Defence of due diligence

25Offences by bodies corporate

PART 7Amendment of primary legislation

27Investigatory powers under the Consumer Rights Act 2015

28Amendment of the Medicines and Medical Devices Act 2021

PART 8Amendment of the Medical Devices Regulations 2002

29Amendments to the Medical Devices Regulations 2002

30Amendment of regulation 2 (interpretation)

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

32Revocation and transitional provision

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

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

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

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

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

PART 9Amendments of other secondary legislation

38Amendment of the Blood Safety and Quality Regulations 2005

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

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

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

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

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

SCHEDULE 1Fees for clinical investigations

SCHEDULE 2Fees in connection with the designation of notified bodies

SCHEDULE 3Provisions breach of which is an offence under regulation 23

2021 No. 905

Medical Devices

Consumer Protection

The Medical Devices (Northern Ireland Protocol) Regulations 2021

Made26th July 2021

Coming into force27th July 2021

The Secretary of State, in exercise of the powers conferred by section 8C of, and paragraph 1(1)(ab) of Schedule 4, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 20181, makes the following Regulations.

A draft of this instrument has been approved by a resolution of each House of Parliament, in accordance with paragraphs 8F(1)2 and 12(1) of Schedule 7 to that Act.

The Treasury has consented to the making of these Regulations as required by paragraph 3(1) of Schedule 4 to that Act.