Regulation 12 General provisions relating to conformity assessment procedures
A notified body which is responsible for carrying out a conformity assessment procedure in connection with a device under regulation 7, 8, 9, 10 or 11 shall, in doing so, take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out under the laws or administrative provisions in force before 1st January 1995 in any EEA State.
Any manufacturer of a device or any notified body shall, in carrying out a conformity assessment procedure for affixing the CE marking to a device, take account of the results of any assessment or verification operations which have been carried out in accordance with the Directive or these Regulations at an intermediate stage of manufacture of the device.
Any procedure set out in Annex III, IV, VII or VIII which, by virtue of these Regulations, is to be followed in the United Kingdom by a manufacturer who has no place of business there may be initiated there by his authorised representative.
Where a conformity assessment procedure involves the intervention of a notified body, the manufacturer of a device or his authorised representative may apply to any notified body which has been designated in accordance with Article 16 of the Directive to carry out tasks in respect of that type of device for the purposes of that conformity assessment procedure.
Where a manufacturer has supplied information or data to a notified body in the course of a conformity assessment procedure, the notified body may require the manufacturer to provide any additional information or data which the notified body considers necessary for the purposes of that procedure.
A decision made by a notified body in accordance with Annex II or Annex III shall—
specify the period of validity of the decision; and
be valid for an initial period of not more than 5 years.
Where an agreement under which a notified body agrees to carry out a conformity assessment procedure for a manufacturer allows the manufacturer to apply to the notified body at a specified time for an extension of the period of validity of a decision mentioned in paragraph (6), the notified body may extend the validity of the decision for further periods of 5 years, each such period commencing on the expiry of the preceding period.
The documentation relating to any of the procedures referred to in this regulation carried out in the United Kingdom shall be in English or, subject to regulation 5(5) and (6), in some other language acceptable to the notified body concerned.
Where the procedures referred to in regulation 7, 8, 9, 10 or 15 have not been carried out in relation to an individual device, the Secretary of State may authorise the placing on the market and putting into service of that device if she is satisfied that this would be in the interest of protection of health.
A manufacturer shall, in following a conformity assessment procedure, observe the manufacturer’s obligations set out in the Annex on that procedure.
In so far as a conformity assessment procedure relates to tasks to be carried out by a notified body, that body shall carry out the notified body’s tasks set out in the Annex on that procedure and shall do so in accordance with that Annex.