UK Offence Report

The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024

UK Statutory Instrument 2024 No. 221 — creates 1 criminal offence.

1offences created
0recorded in force
0revoked
Made
22 February 2024
In force from
21 March 2024
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) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“Regulation (EU) 2017/746”). Article 5(4) of the Windsor Framework between the United Kingdom and the European Union (“the Windsor Framework”) provides that the EU law listed in Annex 2 to the Windsor Framework will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/746 is listed in Annex 2 and applied from 26 May 2022. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/746 in domestic law. Part 2 of these Regulations amends the Human Tissue Act 2004, the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021. The Human Tissue Act 2004 is amended to exclude from its scope devices regulated by Regulation (EU) 2017/746. The Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021 are amended to ensure the enforcement powers they provide for are available in the enforcement of Regulation (EU) 2017/746. Part 3 makes transitional and consequential amendments to secondary legislation. These amendments provide for the definition of “in vitro diagnostic medical device” by reference to Regulation (EU) 2017/746 in Northern Ireland. They also provide for further enforcement powers under the Market Surveillance (Northern Ireland) Regulations 2021 to be available in the enforcement of Regulation (EU) 2017/746. Part 4 amends the Medical Devices (Northern Ireland Protocol) Regulations 2021 (“the 2021 Regulations”). Regulation 33 creates a new Part 2A regarding the making available on the market and putting into service of devices under Regulation (EU) 2017/746. Regulation 34 creates a new regulation A11 setting out new requirements in relation to legal representatives and contact persons in clinical investigations. Similar provisions in relation to performance studies are set out in new Part 3A. Regulation 36 creates a new Part 3A in relation to performance studies under Regulation (EU) 2017/746. Regulations 39 and 43 amend regulation 19 of, and Schedule 2 to, the 2021 Regulations in relation to fees. Regulations 41 and 44 amend regulation 23 of, and Schedule 3 to, the 2021 Regulations to make it a criminal offence to breach a prohibition or requirement in a provision listed in Table 1 or Table 3 in Schedule 3. 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

What Parliament said about it

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How Parliament handled it

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