IVDD vs. IVDR: Classifications Defined and Compared
https://www.thermofisher.com/blog/oempowered/ivdd-vs-ivdr-classifications-defined-and-compared/
Predetermined List of Medical ConditionsThe IVDD’s regulatory classificationwas based on which conditions or pathogens a given diagnostic medical device was designed to diagnose. It grouped those conditions into several extensive lists and annexes. Different lists and annexes with… Here’s What that Means for Diagnostic Device ClassificationThe European Union’s new In Vitro Diagnostic Medical Device Regulation (IVDR) becomes law near the end of May this year, replacing the previous regulatory regime, the In Vitro Diagnostic Medical Device Directive (IVDD). Diagnostic devices sold in the European Union (EU) will face …
Predetermined List of Medical ConditionsThe IVDD’s regulatory classificationwas based on which conditions or pathogens a given diagnostic medical device was designed to diagnose. It grouped those conditions into several extensive lists and annexes. Different lists and annexes with…
Here’s What that Means for Diagnostic Device ClassificationThe European Union’s new In Vitro Diagnostic Medical Device Regulation (IVDR) becomes law near the end of May this year, replacing the previous regulatory regime, the In Vitro Diagnostic Medical Device Directive (IVDD). Diagnostic devices sold in the European Union (EU) will face …
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