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Regulation 10 Procedure for affixing CE marking for Class III devices

Original text. Later amendments are not shown.

A device falling within Class III 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; or

(b)

follows the EC type-examination procedure set out in Annex III, together with—

(i)

the EC verification procedure set out in Annex IV, or

(ii)

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