MDCG Updates Guidance on Standardisation for Medical Devices
The MDCG has updated its guidance on standardisation for medical devices, covering harmonised standards, presumption of conformity, state of the art, common specifications and EU case law.
MDCG publishes guidance on the transition from the ‘EC REP’ to the ‘EU REP’ symbol
The MDCG has published an appendix to MDCG 2021-5 clarifying the transition from the 'EC REP' to the 'EU REP'symbol under EN ISO 15223-1, including a five-year transition period for medical device and IVD manufacturers.
European Commission Publishes Updated Harmonised Standards Under MDR
The European Commission adopts Implementing Decision (EU) 2026/193, updating harmonised standards under MDR (EU) 2017/745.
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.