Europe – IVDR: European Commission publishes second batch of harmonized standards

On Thursday, the European Commission officially recognized five additional harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The standards cover topics including sterilization, aseptic processing, quality management systems, the use of symbols in product information, and requirements for establishing metrological traceability of certain values for calibrators, control materials and human samples…