25.—(1) Where an authorised person has reasonable grounds for considering that instruments to which these Regulations apply and which bear the CE marking do not meet all the appropriate requirements of these Regulations when properly installed and used for the purposes for which they are intended, due to—
(a)failure to meet the essential requirements;
(b)incorrect application of the relevant national standards; or
(c)shortcomings in the relevant national standards,
the following provisions of this regulation shall have effect.
(2) The authorised person shall give notice to the manufacturer or his authorised representative sufficiently describing the instruments to which the notice applies and specifying the respects in which the requirements of the Regulations have not been satisfied.
(3) A notice under this regulation may—
(a)(i)require instruments of the type in question to be withdrawn from the market;
(ii)prohibit or restrict the placing on the market or taking into service of instruments of that type; and
(b)specify that unless steps are taken which ensure—
(i)that the instrument or any instrument of the same type does so conform or comply; or
(ii)that the manufacturer or his authorised representative does so act, as the case may require,
any EC type-approval certificate or any approval of a quality system may be withdrawn.
(4) A notice under paragraph (2) above shall be in writing and shall—
(a)specify the date on which it is to take effect;
(b)specify the grounds for the decision; and
(c)inform the manufacturer of his right to apply for a review of the decision under regulation 20.
(5) Where an authorised person gives a notice under paragraph (2) above, he shall forthwith send a copy of the notice to the Secretary of State.
(6) If the Secretary of State—
(a)in the case of an EC type-approval certificate which he has granted, after giving the manufacturer the opportunity of making representations as to why it should not be withdrawn, decides that the EC type-approval certificate should be withdrawn, he shall immediately—
(i)give notice of the decision to the manufacturer; and
(ii)inform the other member States and the Commission of the decision; or
(b)in the case of an EC type-approval certificate granted under the law of another member State, is of the opinion that consideration ought to be given to whether the EC type-approval certificate should be withdrawn, he shall immediately inform the relevant competent authority of that fact.
(7) If the Secretary of State is of the opinion that consideration should be given to withdrawal of any relevant quality system approval—
(a)in the case of an approval granted by an approved body under these Regulations, he shall inform the approved body of that fact; and
(b)in the case of an approval granted under the law of another member State, he shall immediately inform the relevant competent authority of that fact.
(8) The Secretary of State shall publish, in such manner as he may consider appropriate, particulars of any notice under paragraph (6) above withdrawing an EC type-approval certificate.
Commencement Information
I1Reg. 25 in force at 1.1.2001, see reg. 1(1)