3.3.Without prejudice to Article 13 of this Directive, the notified body shall effect an audit of the quality system to determine whether it meets the requirements referred to in 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards.U.K.
The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. [F1The evaluation procedure shall include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.]
Textual Amendments
F1 Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).
The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation.