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IVD 98/79/EC In-Vitro Diagnostic Medical Devices Services
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EAAR MEMBER
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ISO 9001:2001 |
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Directive IVD 98/79/EEC Article 9,7
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Directive IVD 98/79/EEC Article 9,7 excerpt
The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates, established by Notified Bodies, and make it available to the national authorities for inspection purposes for a period ending five years after the last product has been manufactured. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorized representative.
for complete copy of the Directive, click here
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