Lessons learnt on IVDR technical documentation assessments 

In ensuring successful transition to the new IVD regulation, the TD assessment is a key element of conformity assessment for all IVD medical devices.  

This webinar will share TUV SUD’s experiences with respect to IVDR TD assessments since our notification for IVDR. Our goal is to improve interaction between manufacturers and the Notified Body.   

We will highlight our observations on major challenges while focusing on the most important topics, e.g. TD content and structure, classification, translation of labelling, clinical evidence, traceability of the intended purpose and Class D devices. 


Date and time: Thursday, 11 November 2021, 11.30 am (CET)

Your speaker: Dr Ines Labugger | Product Specialist for invitro diagnostic devices                       

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