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Guidance MEDDEVs

Medical Device: Guidance Document
Guidance on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices
January2012
MEDDEV 2.1/6

Guidelines on Medical Devices
Post Market Clinical Follow-up Studes: A Guide for Manufacturers and Notified Bodies
January 2012
MEDDEV 2.12/2 re.2

Guidelines on Medical Devices
Clinical Investigations: Serious Adverse Event Reporting
December 2011
MEDDEV 2.7/3