IVDs are tools and instruments used to perform tests on patient samples, such as blood, urine, tissue or other bodily fluids, taken from the human body. These devices are used to detect diseases, conditions or infections, monitor health status and determine treatments or medication dosages.
What is the IVDR?
The EU IVDR (2017/746) entered into force on May 26, 2017, replacing the EU In Vitro Diagnostic Medical Device Directive (IVDD). IVDs placed on the EU market must be certified against the new requirements.
The IVDR aims to improve the safety and efficacy of IVDs, ensuring patient clinical safety and creating a transparent and robust framework for manufacturers and healthcare professionals.
Key changes from the IVDD include:
- Expanded scope of products to be considered IVDs
- Changes in device classification (from Class A devices with the lowest risk to Class D devices with the highest risk)
- Stricter oversight of manufacturers by NBs
- Enhanced requirements for post-market surveillance
- Increased transparency through the Unique Device Identification (UDI) system and European Database on Medical Devices (EUDAMED)