As many industry stakeholders may be aware, an amendment to ISO 15223-1:2021 was released last month. This update has generated some uncertainty among manufacturers regarding its implications and the necessary next steps. This article aims to clarify the key elements of the amendment and provide practical guidance on how to respond.
It is important to note that the updated standard has not yet been harmonised with the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Therefore, while we advise our clients to begin preparing for the changes introduced by the amendment, we recommend holding off on formal implementation until harmonisation is confirmed.
The amendment focuses on three main areas, these being the following
Addition of Defined Term for Authorised Representative
The amendment formally introduces a standardised definition for the term “authorised representative” within the context of medical device labelling. This addition is intended to promote greater clarity and uniform interpretation among global stakeholders and regulatory bodies. The definition aligns with the definition that is found on the ISO 13485 and can be seen below:
Definition of Authorised Representative: natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation
Modification of Authorised Representative Symbol
A revision to the symbol denoting the “European Community Representative” has been implemented, replacing “EC REP” with “EU REP”. This update removes regional specificity, making the symbol more adaptable for international use. The change supports manufacturers and authorized representatives operating across multiple markets by streamlining labelling requirements and minimizing the need for region-specific variations.
Use of Country Codes
The amendment also stipulates the use of recognized country codes in the updated symbol. The placeholder “[XX]” is to be replaced with a standard two-letter (e.g., CH for Switzerland) or three-letter (e.g., NZL for New Zealand) code, as applicable in the relevant jurisdiction. This enhancement further broadens the symbol’s applicability and reduces dependency on geographically limited identifiers
The amendment that is currently published on the ISO website can be accessed using the following link
