European Commission Publishes New Harmonised Standards for Sterilisation and IVD Labelling under IVDR
The European Commission has adopted Commission Implementing Decision (EU) 2026/197 of 28 January 2026, amending Implementing Decision (EU) 2021/1195 by adding new references to harmonised standards supporting Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The Decision was published in the Official Journal of the European Union on 30 January 2026 and entered into force on the same day.
MDCG 2020-16 Rev. 4: Update on the Classification of In Vitro Diagnostic Devices (IVDs)
MDCG has published Revision 4 of MDCG 2020-16, updating the classification of in vitro diagnostic medical devices (IVDs) in accordance with IVDR Regulation (EU) 2017/746. Among the main changes is the reclassification of SARS-CoV-2 tests. In addition, adjustments have been made to the classification of blood, tissue and organ screening tests, as well as clarifications for complementary diagnostics and self-tests.