Europe – IVDR: Commission adds risk management standard to harmonized standards list

The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The Commission has now officially added the international risk management standard EN ISO 14971:2019 to its reference list, as well as an amendment to the standard, EN ISO 14971:2019/A11:2021.

In total, the Commission has recognized 10 harmonized standards that can be referenced by test makers to satisfy conformity requirements. The previously recognized harmonized standards relate to sterilization, aseptic processing, quality management systems, the use of symbols, and metrological traceability…