UK Offence Report

Contravention of The Active Implantable Medical Devices Regulations 1992

the instrument as a whole of The Active Implantable Medical Devices Regulations 1992

The provision has been revoked and no saving provision preserving liability for earlier conduct was found.

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 This is the text as originally made; later amendments are not shown here.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 Active Implantable Medical Devices Regulations 1992.

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
Revoked
Revoked by
The Medical Devices Regulations 2002
Revoked on
13 June 2002
Made
10 December 1992
In force from
1 January 1993
Extent
Not stated

How this was established: the instrument was revoked by a later instrument found in this corpus.

What the instrument is for

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

These Regulations (“the Regulations”) implement Council Directive 90/385/EEC (“Directive”) on the approximation of the laws of the Member States relating to active implantable medical devices (OJ No. L189, 20.7.90, p. 17). The Directive is based on the Council resolution of 7 May 1985 on a new approach to technical harmonisation and standards (OJ No. C136, 4.6.85, p. 1). It lays down essential safety requirements which active implantable medical devices (“devices”) must satisfy. Regulation 3 provides that devices placed on the market or put into service must comply with the relevant essential requirements (set out in Schedule 2) and sets out the factors to be taken into consideration in deciding whether the device meets the essential requirements. Regulation 4 requires devices other than custom-made devices or devices intended for clinical investigation to bear the EC mark. Regulation 4 also prohibits the use of a mark which is likely to be confused with the EC mark. Regulation 5 provides that a device may bear the EC mark only if its manufacturer— a follows the EC declaration of conformity procedure as set out in Schedule 5 or b follows the EC type-examination procedure as set out in Schedule 6, together with i the EC verification procedure as set out in Schedule 7, or ii the EC declaration of conformity to type procedure as set out in Schedule 8. Regulation 6 and Schedule 4 contain rules in respect of custom-made devices. Regulation 7 and Schedule 4 contain rules in relation to devices intended for clinical investigation. Regulation 8 provides for the approval of notified bodies to carry out tasks in relation to regulation 5 and Schedule 9 sets out the conditions which notified bodies must meet. Regulation 5(8) to (11) makes provision for the fees chargeable by the notified bodies for work done under the Regulations. Regulation 9 creates offences and regulation 10 provides that the Regulations are to be regarded for the purposes of enforcement as safety regulations and safety provisions as defined in the Consumer Protection Act 1987, although they are made partly in exercise of other powers. Transitional provisions are provided for in regulation 11. Regulation 12 provides for the notification of decisions by the Secretary of State and the notified body.

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