The MDCG Standards subgroup met on 4 February 2026, and published its meeting minutes and presentations: HERE

Below we cover two of the discussion points.

EN ISO 15223-1:2021 and EU REP symbol

In March 2025, ISO 15223-1:2021 was updated to 1) introduce a new definition for “authorized representative”, and 2) add a new “XX REP” symbol. This allows other markets who utilize ISO standards to adopt this symbol in their markets, e.g., UK REP to identify the UK Responsible Person.

The above amendment to ISO 15223-1:2021 has not been harmonized in Europe yet. Once harmonized, it would replace the EC REP symbol with the EU REP identification symbol.

The Standards working group meeting minutes note:

Timing: “It should be offered to the Commission for citation in the OJEU by March 2026, with an appropriate transition period.” This does not mean it will be published March 2026; but that it is available for the Commission to do so, when they feel it is appropriate.

Transition Period: The Commission will implement a transition period for this change, as it will impact every manufacturer on the market. The length of the transition period will be noted when its use is formally published in the Official Journal of the EU (OJEU).

MedTech Europe: “made reference to the costs and timing necessary to implement labelling changes in manufacturing, taking into account the processes involved, as well as the international impact of the envisaged changes”. And therefore: “asked for allowing flexibility/staggered approach for labelling layers during a transition period that should be of 5-6 years time”.

The Commission will circulate MedTech Europe’s presentation, and request that member states and stakeholders present their views on an appropriate transition period in writing.

Guidance: The Commission will draft a guidance/position paper to clarify implementation of the new symbol. It will be available at the same time the new symbol is harmonized in the OJEU.

ISO and IEC vs EC Court Case Update

Court Case T-631/24 is still pending. This case was brought forth by ISO and IEC against the European Commission (EC), related to the release of non-harmonized standards by the EC.

This court case resulted in a slowdown in harmonized standards, with no ISO/IEC standards harmonized for over one year, despite the urgent need for them. Finally in January 2026, additional ISO/IEC standards were harmonized (the last time being October 2024).

While the court case is still ongoing, the the parties were able to come an interim agreement, allowing the continued harmonization of standards:

“…latest useful progresses took place towards possible agreements between COM, CEN-CENELEC and ISO and IEC to make the texts of international-based European harmonised standards available again and retake their citation in the OJEU, as already started in the most recent and upcoming publications…”