EC gives medtech five years to adopt revised symbols standard

Following the November 2025 publication of Amendment 1 to EN ISO 15223-1:2021, the medical device industry has been concerned about the timescale for introduction of the revised symbol for ‘Authorised Representative’, which changes from EC:REP to EU:REP.

The standard with its amendment has now been harmonised and so is suitable for conferring a presumption of conformity when used to comply with the requirements of current device regulations. Normal transition times for new standards are three years from publication of the new standard, but in the case of EN ISO 15223-1:2021 + A1:2025, the European Commission has now published an appendix to an existing guidance that includes a five-year transition for the amended standard.

The Commission has given manufacturers five years to implement the change “considering the significant time and money involved in making labeling changes in manufacturing and distribution of devices, taking into account the processes involved, both at EU and international levels.”

Copies of guidance MDCG 2021-5 Rev.1, ‘Guidance on standardisation for medical devices – Appendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1′, are available from the Commission website.