New harmonised standards for Medical Devices and In Vitro Diagnostics Regulations and EC-EU REP
Posted on 02.07.2026
New references to harmonised standards supporting the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) were published in the Official Journal of the European Union.
MDR
- The update adds references covering, among others, biological evaluation, symbols, medical electrical equipment, transfusion equipment, ophthalmic optics, surgical implants, washer-disinfectors, prosthetics and sharps injury protection.
- The MDR now includes 65 harmonised standard references in total.
IVDR
- The update adds the reference to the amended harmonised standard on symbols used with information supplied by the manufacturer.
- The IVDR continues to include 23 harmonised standard references in total.
Both publications include the reference to EN ISO 15223-1:2021/A1:2025, introducing the new “EU REP” symbol for authorised representatives.
A 60-month (5-year) transition period has been granted in the end, ending on 17 June 2031, following calls from stakeholders to ensure a seamless transition.
In addition, the MDCG is expected to shortly publish a supporting guidance document, “Transition to the ‘EU REP’ symbol in EN ISO 15223-1”, as an appendix to MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices, updated with the publication references.
For more information, please contact Jana Russo, Senior Expert Medical Devices