Xavi&Rea Solutions



In Vitro Diagnostic
Medical Devices (IVD)


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2. In Vitro Diagnostic Medical Devices (IVD)



Definition:
In Vitro Diagnostic Medical Devices are tests and instruments used to examine specimens (e.g., blood, tissue) for diagnosing diseases or monitoring health conditions. Examples include pregnancy tests, blood glucose monitors, and COVID-19 test kits.





EU Regulations:

  • Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, IVDR): Regulates IVDs, requiring CE marking and Notified Body involvement for most risk classes (A, B, C, D).
  • Key Requirements: Risk-based classification, performance evaluation, technical documentation, QMS, and post-market performance follow-up.
  • Our Role: As a Notified Body, we conduct conformity assessments (e.g., Annex IX, X, XI) and provide certification to ensure IVD compliance with IVDR.


Xavi&Rea Solutions



Company Registration Number: C 112273
SOHO St. Julians Punchbowl Centre, Elia Zammit Street
ST. JULIANS STJ 3154 MALTA