We have prepared a document that contains IVDR General Safety and Performance Requirements in a tabular format
Tip:
In IVDR
– the only self-certified devices are the ones falling under Rule 5 (e.g. products for general laboratory use, buffers, general culture media, histological stains, instruments for IVD procedures and specimen receptacles)
– products falling under rule 6 (i.e. the ones not covered by any other Rule) require Notified Body certification
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