ANNEX VU.K.EC DECLARATION OF CONFORMITY(Production quality assurance)
[6. Application to devices in Class IIa U.K.
In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:
6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them. U.K.
6.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive. U.K.
6.3. In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken. U.K.
6.4. Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.] U.K.