Conformity assessment proceduresU.K.
6.—(1) The conformity assessment procedures are the procedures as follows—
(a)for mechanical systems—
(i)B and D;
(ii)B and E;
(iii)B and F;
(iv)D1;
(v)F1;
(vi)G; or
(vii)H1;
(b)for electromechanical instruments—
(i)B and D;
(ii)B and E;
(iii)B and F;
(iv)G; or
(v)H1; and
(c)for electronic systems or systems containing software—
(i)B and D;
(ii)B and F;
(iii)G; or
(iv)H1.
(2) The manufacturer or his authorised representative shall provide to the notified body carrying out the relevant conformity assessment procedure the technical documentation set out in Schedule 3.
(3) In this regulation—
(a)“B” means type examination, set out in Annex B;
(b)“D” means declaration of conformity to type based on quality assurance of the production process, set out in Annex D;
(c)“D1” means declaration of conformity based on quality assurance of the production process, set out in Annex D1;
(d)“E” means declaration of conformity to type based on quality assurance of final product inspection and testing, set out in Annex E;
(e)“F” means declaration of conformity to type based on product verification, set out in Annex F;
(f)“F1” means declaration of conformity based on product verification, set out in Annex F1;
(g)“G” means declaration of conformity based on unit verification, set out in Annex G; and
(h)“H1” means declaration of conformity based on full quality assurance plus design examination, set out in Annex H1