· "List of regulatory positions and
qualifications" AFSSAPS
· ROHS directive applicable to medical
devices
· Manual on borderline and classification
in the community regulatory framework for medical devices
· Communication of IIa,
IIb, III class medical devices and AIMDD FRANCE AFSSAPS
· European Medical Device Usability
Requirements (EN 62366)
· Medical directive Directive
“Recast”
· European Commission publishes draft
regulation on electronic instructions for use of medical devices
· USA FDA Medical Device Pre-Market Programs
· IEC / 60601‐1 and related standards
· Harmonized standards for Medical Devices
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