The Medical Devices (Northern Ireland Protocol) Regulations 2021

EXPLANATORY NOTE

(This note is not part of the Regulations)

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.