The Medical Devices (Northern Ireland Protocol) Regulations 2021

UK Statutory Instrument 2021 No. 905 — creates 1 criminal offence.

1offences created

0recorded in force

0revoked

Made: 26 July 2021
In force from: 27 July 2021
Extent: Not stated
Subject: Food, consumer protection, trading standards, product safety and age-restricted sales
Made under: Schedule 7 to, the European Union (Withdrawal) Act 2018

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017) (“Regulation (EU) 2017/745”). Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement between the United Kingdom and the European Union (“the Protocol”) provides that the EU law listed in Annex 2 to the Protocol will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/745 is listed in Annex 2 and applied from 26 May 2021. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/745 in domestic law. Part 2 of these Regulations makes supplementary provision in relation to placing devices on the market and putting devices into service in Northern Ireland under Regulation (EU) 2017/745. Part 3 makes provision in relation to clinical investigations in Northern Ireland under Regulation (EU) 2017/745. Regulation 16 and Schedule 1 set out the fees for making applications and notifying of substantial modifications. Part 4 of these Regulations makes provision in relation to notified bodies. It provides that the Secretary of State is the authority responsible for notified bodies under Article 35 of Regulation (EU) 2017/745. Regulation 19 and Schedule 2 set out the fees for making applications and for on-site assessments and reviews. Part 5 makes general provision about language requirements and the fees imposed by these Regulations. Part 6 deals with enforcement. Regulation 23 makes it a criminal offence to breach a prohibition or requirement in a provision listed in Table 1 or Table 2 in Schedule 3. Table 1 lists regulations in these Regulations and Table 2 lists Articles in Regulation (EU) 2017/745. Regulation 26 confers duties on the Secretary of State and each district council in Northern Ireland to enforce these Regulations and Regulation (EU) 2017/745. Part 7 amends the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021. Part 8 amends the Medical Devices Regulations 2002. Regulation 32 revokes parts of the Medical Devices Regulations 2002 as they apply to Northern Ireland, and makes transitional provision. The Medical Devices Regulations 2002 implemented Directives 90/385/EEC and 93/42/EEC, which are repealed by Regulation (EU) 2017/745. Regulations 33, 36 and 37 insert provision about the size of the UK(NI) indication. The requirement to affix the UK(NI) indication is imposed by Article 7(3) of the Protocol. Part 9 makes consequential amendments to other pieces of secondary legislation. A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public or voluntary sector is foreseen. The Explanatory Memorandum is published alongside these Regulations on www.legislation.gov.uk.

Offences created by this instrument

A person commits an offence if the person contravenes a prohibition or fails to comply with a requirement in a… regulation 23(1) · Status not determined · Strict liability

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

Medical Devices (Northern Ireland Protocol) Regulations 2021 Lords · Grand Committee · 12 July 2021
Draft Medical Devices (Northern Ireland Protocol) Regulations 2021 Commons · General Committees · 15 July 2021 · The Minister for Health (Edward Argar)
I beg to move, That the Committee has considered the draft Medical Devices (Northern Ireland Protocol) Regulations 2021. It is a pleasure to serve under your chairmanship, Dr Huq. Today we are debating an instrument that is necessary to maintain the regulatory landscape for medical devices in Northern Ireland following a change in European Union law. It reflects the recent application of Regulation (EU) 2017/745 on medical devices in Northern Ireland, which applies to all general medical devices, but not to in vitro diagnostic medical devices. For simplicity, I will hereafter refer to the EU…
Draft Medical Devices (Northern Ireland Protocol) Regulations 2021 Commons · General Committees · 15 July 2021
Business without Debate Commons · Commons Chamber · 19 July 2021 · Mr Speaker
With the leave of the House, we shall take motions 3 to 5 together. I do not think there are any objections to doing so. Motion made, and Question put forthwith (Standing Order No. 118(6)), Aquaculture That the draft Fisheries Act 2020 (Scheme for Financial Assistance) (England) Regulations 2021, which were laid before this House on 15 June, be approved. Public Health That the draft Motor Fuel (Composition and Content) and the Biofuel (Labelling) (Amendment) (No.2) Regulations 2021, which were laid before this House on 21 June, be approved. Medical Devices That the draft Medical Devices…
Medical Devices (Northern Ireland Protocol) Regulations 2021 Lords · Lords Chamber · 20 July 2021
Draft Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations Commons · General Committees · 12 May 2025 · Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
It is a pleasure to serve under your chairmanship, Sir Desmond. The draft regulations will make amendments to the Medical Device Regulations 2002, the Blood Safety and Quality Regulations 2005 and the Medical Devices (Northern Ireland Protocol) Regulations 2021. The core changes made by the draft regulations will include modifying the fees charged to manufacturers, suppliers and relevant stakeholders involved in medical device approval and blood safety monitoring. These amendments will align with updated economic assessments on the operational needs of regulatory bodies. They follow an…
Draft Medical Devices (Fees Amendment) Regulations 2026 Commons · General Committees · 21 January 2026 · The Parliamentary Under-Secretary of State for Health and Social Care (Dr Zubir Ahmed)
I beg to move, That the Committee has considered the draft Medical Devices (Fees Amendment) Regulations 2026. It is a pleasure to serve under your chairship, Ms Jardine. I am grateful for the opportunity to open the debate on these regulations, which were laid before Parliament on 16 December 2025 and are due to come into force on 1 April 2026. The purpose of the regulations is to amend the Medical Devices Regulations 2002 and the Medical Devices (Northern Ireland Protocol) Regulations 2021 to update their fee structure. They do that by introducing a new medical devices registration fee,…

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