A new edition of I.S. EN ISO 15223-1:2021 – Symbols to be used with information to be supplied by the manufacturer - has been published by NSAI.
This standard specifies symbols used to express information supplied for a medical device. The symbols can be used on the device itself or its packaging or the accompanying information. This is a standard that applies to all types of medical devices and is used to support regulatory requirements.
The new edition does include annexes addressing both the MDR (EU 2017/745) and the IVDR (EU 2017/746), however the standard is not considered as “harmonised” until it is cited in the Official Journal of the EU. It is not until the standard is cited will the “presumption of conformity” to medical device regulation apply. The Commission are planning a new citation listing before the end of 2021 and it is expected that this standard will be included.
Manufacturers should develop and plan any changes to their labelling and packaging documents to meet the requirements of this new standard. Notified bodies need to be informed of significant changes to products therefore it is advisable to discuss plans to implement the necessary changes and lead times required to meet the standard with their Notified body.
The standard is available on the NSAI published standard catalogue below.