The MDCG has updated the guidance document MDCG 2021-5 to include the addition of an appendix which aims to aid manufacturers transition to the new ‘EU REP’ symbol.
The European Commission has confirmed a five-year transition period for the implementation of Amendment A1:2025 to harmonised standard EN ISO 15223-1:2021, which introduces the new ‘EU REP’ symbol for authorised representatives in the European Union.
Although the amended standard, EN ISO 15223-1:2021/A1:2025, has replaced the previous version in the Official Journal of the European Union (OJEU), the Commission has postponed the withdrawal of the original standard until 17 June 2031. This decision was made in response to concerns from industry stakeholders regarding the time and resources required to update device labelling, packaging, and related processes.
During this five-year coexistence period, manufacturers may continue to use either the existing ‘EC REP’ symbol under EN ISO 15223-1:2021 or the new ‘EU REP’ symbol under the amended standard to demonstrate compliance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The Commission has also clarified that, during the transition period, manufacturers may adopt a phased implementation approach. This includes using different symbols on different packaging levels or applying relabelling and over-labelling solutions, provided the authorised representative information remains clear and understandable.
From 17 June 2031, only the amended standard incorporating the ‘EU REP’ symbol will provide presumption of conformity with the relevant MDR and IVDR requirements. However, devices already placed on the EU market before that date bearing the ‘EC REP’ symbol may continue to be made available, as the change relates solely to labelling and does not affect the safety, performance, or effectiveness of the device.
The updated guidance document can be accessed using the following link
