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Council Directive 93/42/EECShow full title
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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- Revised 11/10/20070.26 MB
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Changes over time for: Division 3.3.
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3.3.The notified body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements.U.K.
The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers to inspect the manufacturing processes.
The decision must be notified to the manufacturer after the final inspection and contain the conclusions of the inspection and a reasoned assessment.
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