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Europaisches Patent amt (19) European Patent Office European DES brevet seen EP 0 795 341 A1 E U R O P E A N PATENT A P P L I C A T I O N (12) (43) Date of publication: 17.09.1997 Bulletin 1997/38
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What is medical devices - european?
Medical devices - European refers to medical devices that comply with the regulations set forth by the European Union in order to be marketed and used within the EU member states.
Who is required to file medical devices - european?
Manufacturers, importers, and distributors of medical devices are required to file with the appropriate regulatory authorities in order to market their products in the European Union.
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To fill out medical devices - European documentation, companies must provide detailed information about the product, including its intended use, technical specifications, risk assessment, and compliance with EU regulations.
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The purpose of medical devices - European regulations is to ensure the safety, efficacy, and quality of medical devices being marketed and used within the European Union.
What information must be reported on medical devices - european?
Information that must be reported on medical devices - European includes product identification, classification, labeling, instructions for use, conformity assessment, and post-market surveillance data.
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