IVD

IVDR replaces the previous In Vitro Diagnostic Directive (IVDD) to address advances in technology, establish a robust regulatory framework, and enhance patient safety. Key changes include:

• Consideration of modern technologies.
• Enhanced certification with a strict classification system and increased transparency.
• Greater emphasis on patient safety through stringent data requirements and device tracking.

Classification and Timeline

IVDs in the EU are categorized into four risk classes (A, B, C, D), with varying levels of risk to patient and public health. New devices must comply with IVDR before market entry, and legacy devices must transition according to specified timelines.

Six Steps to IVDR Compliance

1. Qualification and Classification: Determine if your product is an IVD and classify it (classes A, B, C, D).
2. Prepare Technical Documentation: Update technical documentation as per IVDR Annex II.
3. Quality Management System (QMS): Update your QMS following IVDR Annex IX, Chapter I.
4. Notified Body: Submit documentation for review if your device is class B, C, or D.
5. Receive Certification: Obtain a certificate of conformity from the Notified Body.
6. Maintain Compliance: Continue to monitor and assess device safety and performance.