Amazon In Vitro Diagnostics Medical Device Directive (IVDD) and Regulation (IVDR) | Simply explained

In Vitro Diagnostics Medical Device Directive (IVDD) and Regulation (IVDR)

The In Vitro Diagnostics Medical Device Directive (IVDD, 98/79/EC) and the In Vitro Diagnostics Medical Device Regulation (IVDR, EU 2017/746) establish standards for in vitro diagnostic devices sold in the EU. These frameworks safeguard product safety and ensure compliance with European norms.

  • Purpose: They standardize the quality, safety, and performance of in vitro diagnostic medical devices.
  • Compliance: Devices must adhere to these regulations to be sold in the EU, requiring certification and documentation.
  • Documentation: Includes the EC Declaration of Conformity, CE marking, and other specified labels and certificates.

These regulations apply to manufacturers, importers, and distributors within the EU, with stricter requirements under IVDR compared to the preceding IVDD. Compliance is mandatory for market access in the EU.

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