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CE Marking Medical Devices
CE Marking
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New Regulations MDR/IVDR
MDR – Medical Devices Regulation (EU) 2017/745
IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
Certificates of Free Sale
AIMDD – Active Implantable Medical Devices Directive
MDD – Medical Devices Directive
IVDD – In Vitro Diagnostic Medical Devices Directive
OEM – Private Labeling
Technical File Compilation
Declaration of Conformity
CE Consulting Electrical Equipment
EMC – Electromagnetic Compatibility Directive
LVD – Low Voltage Directive
CE Consulting Environmental Requirements
WEEE – Waste Electrical and Electronic Equipment
RoHS – Restriction of Hazardous Substances
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EU Authorized Representative Responsibilities
EU Authorized Representative vs. Distributor
MDR
About the Medical Devices Regulation (EU) 2017/745
Major Aspects of the MDR
IVDR
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Major Aspects of the IVDR
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Full collection of charts about the Conformity Assessment Routes under the MDR