- Latest available (Revised)
- Original (As made)
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
You are here:
- UK Statutory Instruments
- 1995 No. 1671
- Regulation 5
What Version
More Resources
Status:
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
Amendment of regulation 4 of the principal Regulations
5.—(1) Regulation 4 of the principal Regulations (EC mark) shall be amended in accordance with the following provisions of this regulation.
(2) In paragraph (1) for the words “accompanied by the relevant notified body logo” there shall be substituted the words “followed by the relevant notified body identification number”.
(3) In sub-paragraph (b) of paragraph (1) there shall be inserted at the beginning the words “where appropriate,”.
(4) In paragraph (3) for the words “a mark which is likely to be confused with the EC mark” there shall be substituted the words “a marking which is likely to deceive third parties as to the meaning and form of the CE marking”.
(5) After paragraph (3) there shall be added the following paragraphs—
“(4) Any other marking may be affixed to a device’s packaging or to the instruction leaflet accompanying the device, provided that the visibility and legibility of the CE marking are not thereby reduced.
(5) Where a device comes within the scope of a directive other than the Directive and that other directive provides for the affixing of the CE marking, the CE marking shall not be affixed unless the relevant requirements of that other directive are also satisfied.
(6) Where a directive other than the Directive permits a manufacturer to choose which arrangements to apply during a transitional period, the CE marking shall indicate that the device fulfils only the provisions of those directives applied by the manufacturer.
(7) In a case falling within paragraph (6), particulars of the directives applied by the manufacturer, as published in the Official Journal of the European Communities, shall be given in the documents, notices or instructions required by the directives and accompanying the device, and these documents, notices or instructions shall be accessible without it being necessary to destroy the packaging which keeps the device sterile.”.
Options/Help
Print Options
PrintThe Whole Instrument
PrintThis Section only
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.