Latest / Medical Device made Easy Podcast
How to certify a self-testing device under IVDR? [Erik Vollebregt]
We have talked enough about EU MDR so this week we will help the IVD Companies with the requirements for Self-testing devices under IVDR. Self-tests or near-patient tests are problematic because they are used by laypersons which are not professionals on the way to use or interpret the result of such a device.
So, some particular care is provided by the regulators to verify that a layperson really understands how these device work and to avoid some misinterpretation.
Erik Vollebregt will be helping us to understand this situation and we will also talk about certain stories we were…
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