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There are outstanding changes not yet made by the legislation.gov.uk editorial team to The Medical Devices (Northern Ireland Protocol) Regulations 2021. Those changes will be listed when you open the content using the Table of Contents below. Any changes that have already been made by the team appear in the content and are referenced with annotations.
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Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):
PART 2 Making available on the market and putting into service under Regulation (EU) 2017/745
PART 3 Clinical investigations under Regulation (EU) 2017/745
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
17.Clinical investigations not carried out for a purpose specified in Article 62(1)
PART 4 Notified bodies designated under Regulation (EU) 2017/745
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
PART 5 General provision about language requirements and fees
PART 8 Amendment of the Medical Devices Regulations 2002
31.Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods)
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
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