SequencingJames
Registered
Dear all
When looking at Reproducibility testing under IVDR, are there any specific requirements about where this testing must be conducted?
The FDA require that at least 2 labs should be located in the USA. Are there any such requirements under IVDR?
I can't find anything in the regulation, from MDCG or in CLSIs that say where this must be done, just that it is needed.
Thanks for any help you can offer
When looking at Reproducibility testing under IVDR, are there any specific requirements about where this testing must be conducted?
The FDA require that at least 2 labs should be located in the USA. Are there any such requirements under IVDR?
I can't find anything in the regulation, from MDCG or in CLSIs that say where this must be done, just that it is needed.
Thanks for any help you can offer
