EN ISO 13485 And Symbols Standards Harmonized Under EU's IVDR

The European version of the international risk management standard, EN ISO 14971:2019, may have slipped through the net this January, but the European Commission has just published five new standards harmonized under the IVD Regulation.

With four months to go until the IVD Regulation applies in the EU, the amended EU medtech quality system standard, EN ISO 13485: 2016 A 11, and four other IVD standards have been published in the Official Journal of the EU as harmonized in the context of the EU IVDR.

There are now a total of nine references standards harmonized in the context of the IVD Regulation following this latest...