Transcription of Title: Post-Marketing Surveillance (PMS) post …
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Co-ordination of Notified Bodies Medical Devices Recommendation (NB-MED). on Council Directives 90/385/EEC, NB- 93/42/EEC and 98/79/EC. title : Post-Marketing Surveillance (PMS). post market/production Chapter: Market Surveillance ; vigilance Text: "MDD" undertaking by the manufacturer to keep up to date a systematic procedure to review "Experience gained from devices in the post - Production phase". "AIMD" undertaking by the manufacturer to institute and keep updated a Post-Marketing Surveillance (PMS) system. IVD The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post - production phase Key words: Surveillance , registration card, vigilance Post-Marketing Surveillance Manufacturers must have an appropriate system for gaining and reviewing experi- ence in the post production phase from the range of devices he manufactures.
Co-ordination of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Recommendation NB-MED/2.12/Rec1
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