UK Offence Report

Amendment to regulation 23 (offence of breaching certain provisions)

regulation 41 of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024

This offence was read from the text as made, and no revised version was available, so a later revocation could not be ruled out. Check the current text at legislation.gov.uk.

What the provision says

41 For regulation 23(1) substitute—

1 A person commits an offence if the person contravenes

a prohibition or fails to comply with

a requirement in

a provision of—

a the regulations listed in Table 1;

b the articles of Regulation (EU) 2017/745 listed in Table 2;

c the articles of Regulation (EU) 2017/746 listed in Table 3; in Schedule

3 to these Regulations. .

Text as made, from legislation.gov.uk. © Crown copyright, reused under the Open Government Licence v3.0. This is the text as originally made; later amendments are not shown here.

Who it binds, and what has to be proved

Binds
a person
Conduct
failing to comply with a notice or direction
Fault element
Strict liability
Burden of proof
No statutory defence — prosecution proves everything

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that a person meant to do it, knew about it, or was careless.

Intention, knowledge and carelessness are irrelevant to guilt. They may still matter a great deal to sentence.

The provision states no defence, so the prosecution bears the burden on every element of the offence.

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

What would breach regulation 41?

These are illustrations, not law. They are generated from the provision’s own words to show the shape of the offence. Whether any particular conduct is caught depends on the full text, on any amendment since, and on the facts.

  1. Being served with a notice under the Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and doing nothing by the date it specifies.
  2. Doing part of what the notice requires, where it required all of it.
  3. Disagreeing with the notice and ignoring it, rather than using whatever appeal the instrument provides.

Penalty

Mode of trial
Not determined
Maximum fine
Not determined
Maximum prison (summary)
Not determined

no penalty is stated here: this instrument amends another one, and the penalty for the offence is in the instrument being amended.

No penalty was determined from this instrument. It may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence. Absence of a figure here is not evidence that the offence carries no penalty.

Sentencing

Offences of this kind are usually sentenced under the guidelines below. This is a mapping by subject, not a finding about this provision, and the links go to a search of the Sentencing Council’s own site.

Prosecution figures

No published per-offence figure was found for this provision, and it could not be matched to a Ministry of Justice offence code. Offences created by statutory instrument very largely do not have one. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status
Status not determined
Made
22 February 2024
In force from
21 March 2024
Extent
N.I.

How this was established: read from the text as made; no revised version available, so later revocation could not be ruled out.

What the instrument is for

(This note is not part of the Regulations) — the explanatory note published with the instrument, © Crown copyright.

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.

Read the full note and every offence in this instrument

How this was identified as an offence

Everything above rests on the judgement that this provision creates a criminal offence, rather than mentioning one. That judgement is made by rule, from the words of the provision, and this is the rule that made it — with a confidence of 0.92.

Basis
the provision says a person “commits an offence”
Confidence
0.92 of 1.00

A provision that states a penalty for an offence created elsewhere can read very like one that creates an offence, and the rules can mistake the one for the other. If the text quoted above sets a penalty for something made an offence by another provision, treat the classification on this page with that in mind, and read the instrument.

Check the source