are condoms medical devices

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condoms CE mark certifications medical device

Condoms intended for sale or distribution within European Union must carry the CE mark, which verifies that the condom product meets the essential requirements of the medical device directive 93/42/EEC and 2007/47/EC. All the condom Manufacturers are required to follow specific conformity assessment procedures that include submitting a dossier to a European approved Notified Body. Compliance with ISO 4074 can …

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