UK Offence Report

Amendment of the Electro-medical Equipment (EEC Requirements) Regulations 1988

regulation 27(3) of The Medical Devices Regulations 1994

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

3 For regulation 3 (marking) there shall be substituted the following regulation—

3 A person shall be guilty of an offence where he supplies electro-medical equipment—

a which does not comply with the technical requirements contained in Annex I to the Directive; and

i which is marked with the reversed epsilon, (or with

a mark so closely resembling it as to be taken to be the reversed epsilon), or

ii to which

a declaration has been applied; or

b which is also

a medical device for the purposes of the Medical Devices Regulations 1994 and which does not satisfy the essential requirements for that device specified in those 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 This is the text as originally made; later amendments are not shown here.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
selling or supplying something the instrument restricts
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 27(3)?

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. Selling the goods under the Medical Devices Regulations 1994 where the instrument prohibits the sale outright.
  2. Supplying without carrying out a check the instrument requires first, even where the sale would otherwise be lawful.
  3. Offering for sale counts as well as selling: displaying stock is enough where the provision reaches an offer.

Penalty

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

no penalty is stated in this instrument; it may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence.

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
28 November 1994
In force from
21 December 1994
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 (“the Regulations”) implement Council Directive 93/42/EEC (“the Directive”) concerning medical devices. The Directive is based on the Council resolution of 7 May 1985 on a new approach to technical harmonisation and standards. It lays down essential safety requirements which medical devices (“devices”) must satisfy. Regulation 3 specifies those products and substances which are not devices for the purposes of the Regulations. Regulation 4 provides for the classification of devices into Classes I, IIa, IIb and III for the purposes of the Regulations. Regulation 5 provides that devices placed on the market or put into service must comply with the relevant essential requirements as defined by reference to the essential requirements specified in Annex I of the Directive. Regulation 5 also sets out the factors to be taken into consideration in deciding whether a device meets the essential requirements. Regulation 6 requires devices other than custom-made devices or devices intended for clinical investigation to bear the CE marking. Regulation 6 also prohibits the use of a mark which is likely to be confused with the CE marking. Regulations 7, 8, 9 and 10 specify the procedures which manufacturers must follow for affixing the CE marking to devices. Regulation 11 sets out the requirements to be satisfied for placing devices on the market as a system or procedure pack and for CE marked devices designed by manufacturers to be sterilised before use. Regulation 12 contains general provisions relating to the procedures for affixing the CE marking to a device. Regulation 13 specifies the obligations to be met by persons other than manufacturers. Regulation 14 requires persons placing devices on the market to supply the Secretary of State with certain information about themselves and the devices. Regulation 15 specifies, by reference to Annex VIII of the Directive, the rules in respect of custom-made devices. Regulation 16 specifies, by reference to Annex VIII of the Directive, the rules relating to devices intended for clinical investigation. Regulation 17 provides for the approval of the notified bodies which are to carry out tasks as part of a procedure mentioned in regulation 7, 8, 9 or 10. Regulation 17 also requires that such bodies must meet conditions specified in Annex XI of the Directive. Regulation 18 creates offences. Regulation 19 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. Regulation 20 provides for the setting up of a centralised system of records containing information on incidents occurring after devices have been placed on the market. Regulation 21 makes provision for the fees chargeable by the notified bodies for work done under the Regulations. Regulation 22 contains transitional provisions. Regulation 23 provides for the notification of decisions by the Secretary of State and the notified bodies. Regulations 24 and 25 contain amendments required in consequence of the Regulations. Regulation 26 contains amendments required to take account of transitional provisions affecting clinical thermometers. Regulation 27 contains amendments required to take account of changes affecting electro-medical equipment. A cost compliance assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies of the assessment are also available from the Medical Devices Agency, Room 620, 14 Russell Square, London WC1B 5EP.

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 is “guilty of 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