- MED-DEV2.12-1 - Guidelines on a European Vigilance System
- CD2007-47-EC - Amending Active Implantable, Medical Device Directives, Biocidal Products
The latest regulatory documents are now available on The CRO Group - Google share site including:
- FDA-FCC Joint Collaboration MOU - 26 Jul 2010
- MED-DEV 2.12.1 Rev 6 Dec 2009 - European Vigilance Guidance
- MED-DEV 2.7.1 Rev 3 Dec 2009 - Clinical Evaluation
To obtain these as well as others free of charge, please send email to info@ and include "Regulatory Guidances" in the subject line.
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