UK Offence Report

Contravention of The In Vitro Diagnostic Medical Devices Regulations 2000

the instrument as a whole of The In Vitro Diagnostic Medical Devices Regulations 2000 (revoked)

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

Contravening this instrument is an offence under section

12 of the Consumer Protection Act 1987. The instrument itself contains no offence-creating words.

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 This is the text as originally made; later amendments are not shown here.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
breaching the provision
Fault element
Strict liability
Burden of proof
Not determined

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.

Classifier’s reasoning: contravention offences of this kind are strict as to the breach; the fault position is governed by the parent Act and was not read from it.

What would breach the instrument as a whole?

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. Doing what the provision prohibits, or failing to do what it requires under the In Vitro Diagnostic Medical Devices Regulations 2000.

Penalty

Mode of trial
Set by another provision — the instrument states the penalty by reference to an Act or to another regulation
Maximum fine
Not determined
Maximum prison (summary)
Not determined

The instrument does not state a penalty itself. It sets one by reference to section 12 of the Consumer Protection Act 1987.

the penalty is in the parent Act, not in this instrument.

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
11 May 2000
In force from
7 June 2000
Extent
Not stated

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 implement Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (“ the Directive”). Regulation 2 is an interpretation provision. Regulation 3 sets out the scope of the Regulations, and indicates which in vitro diagnostic medical devices are covered by the Regulations (“relevant devices”). Regulation 4 provides that relevant devices placed on the market, put in to service or (in certain circumstances) supplied must comply with the relevant essential requirements, as defined by reference to the essential requirements specified in Annex I of the Directive. Regulation 4 also sets out the factors to be taken into consideration when deciding whether a relevant device meets the essential requirements. Regulation 5 requires relevant devices, their instructions for use and their sales packaging to bear a CE marking which meets the requirements of the Directive. Regulation 6 deals with the CE marking of relevant devices that come within the scope of more than one Directive, and regulation 7 contains prohibitions relating to relevant devices which are not ready for use. Regulation 8 specifies exemptions from the requirements of regulations 4, 5 and 7, including exemptions in the interests of the protection of health. Regulation 9 sets out the procedures which manufacturers must follow for affixing the CE marking to relevant devices, and regulation 10 contains supplemental provisions relating to those procedures, including a number of additional requirements on manufacturers or their authorised representatives. Regulation 11 creates prohibitions relating to the affixing of a CE marking for a relevant device to a product which is not a relevant device. Regulation 12 specifies, by reference to Annex VIII of the Directive, the rules in respect of making available devices for performance evaluation. Regulations 13 and 14 relate to the registration of manufacturers, or their authorised representatives, of relevant devices and devices for performance evaluation, and the information they need to supply to the Secretary of State for registration purposes. Regulation 15 deals with the designation of United Kingdom notified bodies and the circumstances in which such designations may be varied and withdrawn. Regulation 16 specifies the functions of such bodies. Regulation 17 makes provision for the fees chargeable by the notified bodies for work done in connection with the conformity assessment procedures set out in the Annexes to the Directive. Regulation 18 specifies the responsibilities for enforcement in relation to the Regulations, and it provides that the Regulations are to be regarded for the purposes of enforcement as safety regulations as defined in the Consumer Protection Act 1987, although they are made partly in exercise of other powers. It also designates the Secretary of State as responsible for certain public health monitoring activities. Regulation 19 contains a notice procedure for requiring compliance where there is a failure to comply with the requirements of the Regulations, and a further notice procedure for applying restrictions to the availability of devices where this is necessary to ensure the protection of health or safety. Regulation 20 contains transitional provisions, and regulation 21 contains procedural requirements in relation to the notification of decisions by the Secretary of State, other enforcement authorities and the United Kingdom notified bodies. Regulation 22 gives effect to Schedule 1 which contains amendments to the Medical Devices Regulations 1994 which are consequential upon amendments to Council Directive 93/42/EEC concerning medical devices that were included in the Directive. The changes to Council Directive 93/42/EEC were essentially to align the requirements of the two Directives. Some additional changes have also been made to the 1994 Regulations to align the implementation approach adopted in those Regulations with the approach adopted in these Regulations, and there are also changes to the system set out in the 1994 Regulations for obtaining the approval of ethics committees and the Secretary of State for proposed clinical investigations. Regulation 23 gives effect to Schedule 2 which contains amendments to the Medical Devices Fees Regulations 1995 arising out of both the new scheme for in vitro diagnostic medical devices and the scheme in the Medical Devices Regulations 1994. There are new fees in connection with the registration scheme for relevant devices and devices for performance evaluation, as well as a new fee in connection with the registration scheme for certain medical devices. Notified bodies are also required to pay fees in relation to their designation scheme, and for certain inspections by the Secretary of State. The amendments also include some new enforcement provisions for the 1995 Regulations. A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1 6TQ.

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 0.55.

Basis
the penalty comes from the enabling Act rather than from this instrument
Confidence
0.55 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