This seminar will provide you insights into the key regulatory changes of the IVDR, to help you to prepare your organisation and your devices for IVDR compliance.
Cost: SEHTA members fee: £240 + VAT / Non-Members: £280 + VAT per delegate
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The Invitro Diagnostic Regulations are in transition and companies need to understand and prepare for these significant changes. Attendees will 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
-Outline of the Quality System requirements
-Outline of the Performance requirements/Clinical evidence
-Outline of Post Market Surveillance requirements
For further information and to register, please click here.