Transcription of Medical Device Directive (MDD)
{{id}} {{{paragraph}}}
Example: barber
Medical Device Directive (MDD)
Slide 1 of 37 Robert Packard, Device Directive (MDD)93/42/EEC as modified by 2007/47/ECSlide 2 of 37 Robert Packard, Adopted by all Member States Efficient regulation Ensure safe Medical devices Ensure manufacturer responsibility Ensure the product benefits the community Ensure that benefit outweighs risk Market orientationObjectives of New Approach Slide 3 of 37 Robert Packard, DirectivesMedical devices : Medical devices Directive (MDD) 93/42/EEC Active Implantable Medical devices (AIMD) 90/385/EEC In Vitro Diagnostics Directive (IVD) 98/79/EC 4 of 37 Robert Packard, is presumption of conformance with the MDD if the manufacturer bases their quality system on a harmonized standard.
• Risk management per EN ISO 14971:2012 • Preparation of the Declaration of Conformity • Requirements for affixing CE Mark. Slide 7 of 37 Robert Packard, Consultant www.MedicalDeviceAcademy.com rob@13485cert.com. ... Committee on Medical Devices ...
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: