AMA on IVDR

  • 27 May 2022
  • 2 replies
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We invited Kyle Rose from RookQS for an exclusive AMA (ask me anything) session on the topic of the recent the IVDR.

If you have run into problems, send a message directly to @Etienne and let us know!


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Hello, I have some questions for today’s session:

  • IVDs for performance evaluations only are considered “placed in the market” and do they require a Manufacturer’s EU Authorized Representative (on labelling), or they require only the Sponsor’s EU Representative?
  • For IVD used in a combined clinical trial (study where the object of the evaluation is both an IVD and a medicinal product), how can be performed the notification of the combined study to the EU authorities? Are 2 different protocols required and 2 different submissions required? And how is communicated the approval or rejection of the application?
  • For non-interventional studies (where the results obtained from the IVD are not used for patients management) which are the requirements under IVDR? Is the application and approval of EU competent authorities required only for interventional studies (IVDR Art. 58)?
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One of the IVDR courses on IVDR Audit training from Oriel State mentioned on the call

https://www.orielstat.com/courses/eu-ivdr-auditor-training-2017-746

 

Also mentioned was Axeon:

https://axeon.net/

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