Natera Announces IVDR Certification for Signatera™ Across Multiple Cancers
Natera announced that its Signatera personalized molecular residual disease (MRD) test has received Class C certification under the EU’s In Vitro Diagnostic Regulation (IVDR). This certification allows Natera to continue offering Signatera to EU patients after the 2028 IVDD transition deadline and reduces regulatory overhead for launching new clinical trials.
Key figures
- Drug Name
- Signatera
- Device class
- Class C
- Regulatory framework
- IVDR
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