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Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
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The manufacturer shall affix the CE marking in accordance with Article 16 and shall draw up a declaration of conformity covering the devices concerned.
The application must include:
the name and address of the manufacturer and any additional manufacturing site covered by the quality system,
adequate information on the device or device category covered by the procedure,
a written declaration that no such application has been lodged with any other notified body for the same device-related quality system,
the documentation on the quality system,
an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved,
an undertaking by the manufacturer to keep the approved quality system adequate and efficacious,
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action and notification as referred to in Annex III, section 5.
It shall include in particular an adequate description of:
the manufacturer's quality objectives;
the organisation of the business and in particular:
the organisational structures, the responsibilities of the managerial staff and their organisational authority where quality of design and manufacture of the devices is concerned,
the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of design and of product, including control of devices which fail to conform;
the procedures for monitoring and verifying the design of the devices and in particular:
a general description of the device, including any variants planned,
all documentation referred to in Annex III, section 3, indents 3 to 13,
in the case of devices for self-testing, the information referred to in Annex III, section 6.1,
the techniques used to control and verify the design and the processes and systematic measures which will be used when the devices are being designed;
the inspection and quality assurance techniques at the manufacturing stage and in particular:
the processes and procedures which will be used, particularly as regards sterilisation,
the procedures in relation to purchasing,
the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;
the appropriate tests and trials which will be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible to trace back the calibration.
The manufacturer shall carry out the required controls and tests according to the latest state of the art. The controls and tests shall cover the manufacturing process including the characterisation of the raw material and the individual devices or each batch of devices manufactured.
In testing the devices covered by Annex II, List A, the manufacturer shall take into account the most recent available information, in particular as regards the biological complexity and variability of the specimens to be tested with the in vitro device concerned.
The assessment team must have 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 and/or subcontractors to inspect the manufacturing processes.
The decision shall be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.
The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.
the documentation on the quality system,
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculation, tests, etc.,
the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
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