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In Vitro Diagnostic (IVD) New IVDR CE Marking Workshop
Thu 16 Jan
|Webex
The Invitro Diagnostic Regulations are in transition and companies need to understand and prepare for these significant changes.
Registration is Closed
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Time & Location
16 Jan 2020, 14:00 GMT
Webex
About the event
This one day workshop was run by SEHTA and Psephos Biomedica on 16th January 2020.
The Invitro Diagnostic Regulations are in transition and companies need to understand and prepare for these significant changes. The workshop aimed to gain an understanding of:
The new IVD regulations (EU 2017/746), Device Classification and Key Time Lines
Significant differences between the current directive (98/79/EC) and the new IVD Regulations
The role and status of Notified Bodies
Outline of the Technical Documentation including Labelling and EUDAMED
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