UK Offence Report

Offence of breaching certain provisions

regulation 23(1) of The Medical Devices (Northern Ireland Protocol) Regulations 2021

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

1 A person commits an offence if the person contravenes

a prohibition or fails to comply with

a requirement in

a provision of the regulations listed in Table

1 or the Articles listed in Table

2 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 This is the text as originally made; later amendments are not shown here.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 23(1)?

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 (Northern Ireland Protocol) Regulations 2021 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
Summary only — tried in a magistrates’ court
Maximum fine
£5,000
Standard scale
Level 5
Maximum prison (summary)
6 months

in Northern Ireland a reference to a level is construed as referring to the standard scale as it currently stands (Fines and Penalties (NI) Order 1984 art.5(3)), not as it stood when the instrument was made.

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
26 July 2021
In force from
27 July 2021
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) 2017/745 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.

Read the full note and every offence in this instrument

What Parliament said

Mentions of this instrument in Hansard. Parliamentary material is reused under the Open Parliament Licence v3.0.

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