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Regulation 8 Procedure for affixing CE marking for Class IIa devices

Original text. Later amendments are not shown.

A device falling within Class IIa may bear the CE marking only if its manufacturer—

(a)

follows the EC declaration of conformity procedure (full quality assurance system) set out in Annex II, excluding Section 4 of that Annex; or

(b)

follows the EC declaration of conformity procedure set out in Annex VII, together with—

(i)

the EC verification procedure set out in Annex IV,

(ii)

the EC declaration of conformity procedure (production quality assurance) set out in Annex V, or

(iii)

the EC declaration of conformity procedure (product quality assurance) set out in Annex VI.