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The lists of codes and corresponding types of in vitro diagnostic medical devices (IVD) established by the above mentioned Regulation, namely, in its Annex II, ...

2022/5/26 -The IVDR lays down rules concerning the “placing on the market”, “making available on the market” or “putting into service” of IVDs and ...

The new IVDR classification system specifies the risk classes A through D, with A indicating low-risk products and D representing products with the highest ...

2021/3/18 -The IVDR requires conformity assessment by notified bodies. The evaluation of the clinical evidence (scientific validity, analytical performance ...

2024/1/25 -Notably, however, the IVDR introduced a new classification system that means that ~80% of IVDs (namely any IVD falling in Class B, C or D) ...

The In Vitro Diagnostics Regulation (IVDR) is the new regulatory framework which will affect all in vitro diagnostic medical devices on the European market. The ...

Since May 2022, the In Vitro Diagnostic. Medical Devices Regulation (EU) 2017/746 (IVDR) fully applies. Most IVDs are able to benefit from a three to five years ...