The Medical Devices (Northern Ireland Protocol) Regulations 2021
PART 1
Preliminary
1
Citation and commencement
2
Extent and application
3
Interpretation
4
Scope
PART 2
Making available on the market and putting into service under Regulation (EU) 2017/745
5
Reprocessing of single-use devices
6
Requirement on health institutions to provide information relating to implanted devices
7
Registration of custom-made devices
8
Certificates of free sale under Regulation (EU) 2017/745 - fee
9
Retention of documentation relating to conformity assessments and custom-made devices
10
UK(NI) indication under Regulation (EU) 2017/745
Part 2A
Making available on the market and putting into service under Regulation (EU) 2017/746
10A
Certificates of free sale under Regulation (EU) 2017/746 – fee
10B
Retention of documentation relating to conformity assessments
10C
UK(NI) indication under Regulation (EU) 2017/746
PART 3
Clinical investigations under Regulation (EU) 2017/745
A11
Legal representatives and contact persons for clinical investigations
11
Ethical review of clinical investigations
12
Prior authorisation of clinical investigations by the Secretary of State
13
Arbitration following the refusal of a clinical investigation application
14
Damage compensation in relation to clinical investigations
15
Retention of documentation relating to clinical investigations
16
Clinical investigation fees
17
Clinical investigations not carried out for a purpose specified in Article 62(1)
17A
Advice in relation to intended clinical investigations
Part 3A
Performance studies under Regulation (EU) 2017/746
17B
Legal representatives and contact persons for performance studies
17C
Ethical review of performance studies
17D
Arbitration following the refusal of a performance study application
17E
Damage compensation in relation to performance studies
17F
Retention of documentation relating to performance studies
PART 4
Notified bodies designated under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
18
Notified bodies
19
Fees payable in connection with the designation of notified bodies
Part 4A
Fees for consultation in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device
19A
Interpretation of Part 4A
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
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
19D
Fees for pre-consultation meetings
PART 5
General provision about language requirements and fees
20
Language requirements
21
Unpaid fees
22
Waivers, reductions and refunds
PART 6
Enforcement
23
Offence of breaching certain provisions
24
Defence of due diligence
25
Offences by bodies corporate
26
Enforcement
PART 7
Amendment of primary legislation
27
Investigatory powers under the Consumer Rights Act 2015
28
Amendment of the Medicines and Medical Devices Act 2021
PART 8
Amendment of the Medical Devices Regulations 2002
29
Amendments to the Medical Devices Regulations 2002
30
Amendment of regulation 2 (interpretation)
31
Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods)
32
Revocation and transitional provision
33
Amendment of regulation 10A (UK(NI) indication: general medical devices)
34
Amendment of regulation 19 (registration of persons placing general medical devices on the market)
35
Amendment of regulation 21B (registration of persons placing active implantable medical devices on the market)
36
Amendment of regulation 24A (UK(NI) indication: active implantable medical devices)
37
Amendment of regulation 36A (UK(NI) indication: in vitro diagnostic medical devices)
PART 9
Amendments of other secondary legislation
38
Amendment of the Blood Safety and Quality Regulations 2005
39
Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007
40
Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 2007
41
Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
42
Amendment of the Economic Growth (Regulatory Functions) Order 2017
43
Amendment of the Market Surveillance (Northern Ireland) Regulations 2021
SCHEDULE 1
Fees for clinical investigations
SCHEDULE 2
Fees in connection with the designation of notified bodies
SCHEDULE 3
Provisions breach of which is an offence under regulation 23
2021 No. 905

Medical Devices

Consumer Protection

The Medical Devices (Northern Ireland Protocol) Regulations 2021
Made
26th July 2021
Coming into force
27th 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 2018 , 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) 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.
2018 c.16. The European Union (Withdrawal) Act 2018 was amended by the European Union (Withdrawal Agreement) Act 2020 (c. 1) (“the 2020 Act”). Section 8C was inserted by section 21 of the 2020 Act, and paragraph 1(1)(ab) of Schedule 4 by section 28 of that Act. Paragraph 21 of Schedule 7 was amended by paragraph 53(2) of Schedule 5 to the 2020 Act.
Paragraph 8F was inserted by paragraph 51 of Schedule 5 to the 2020 Act.