European regulators just updated the harmonized standards list for the In-Vitro Diagnostic Medical Devices Regulation (IVDR) days ahead of its implementation date on May 26, 2022.
When the European Commission added the international risk management standard EN ISO 14971:2019 to its reference list, it brought the total to 10 harmonized standards that the Commission has recognized which can be referenced by test makers to satisfy conformity requirements. The EC published the news in the Official Journal of the European Union.
In addition to recognizing the risk management standard, the EC also revised the entry for the quality management systems standard ISO 13485 to correct the European forward and informative annexes, which serve as an amendment to, but do not affect the standard itself…
