ANNEX IIU.K.EC DECLARATION OF CONFORMITY(Full quality assurance system)

[F17. Application to devices in Classes IIa and IIb. U.K.

7.3. For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.] U.K.