This symbol is only to be used when there is an accompanying Sterile symbol (5.2.1 to 5.2.5 or 5.2.10). This symbol is not to be used on reusable medical devices that are intended to be sterilized between uses.

GSPR 23.1 of the MDR (GSPR 20.1 of the IVDR) provides the general requirements regarding label and instructions for use, but other GSPRs as well as other articles of the Regulations provide further detailed requisites.

This paper aims to clarify what symbols developed for the MDR compliance may be potentially used by the IVD sector and which ones are not to be used since the IVDR does not make those kinds of requirements.

The symbols below can either be found on the ISO Online Browsing Platform (https://www.iso.org/obp) or in ISO 15223-1:2021. If a symbol is registered in ISO 7000 its numerical reference is included next to the symbol title. Otherwise, symbols not registered in ISO 7000 are found only within ISO 15223-1:2021. Disclaimer

Aug 22, 2024 · The standard ISO 15223-1, regulates the symbols that manufacturers are permitted to/must use for labeling medical devices. In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of relatively few standards under the MDR and added it to the list of harmonized standards .

The Medical Devices Regulation 2017/745/EU (‘MDR’) has new requirements that ask for various kinds of information to be indicated on the label of medical devices.

Jan 31, 2022 · The Medical Devices Regulation (MDR) (2017/745/EU) and in vitro diagnostic medical devices regulations (IVDR) (2017/746/EU) have requirements that ask for various information to be included on the label of medical devices.

Learn the Importance of Medical Device Symbols for Labeling. Follow ISO 15223-1 for Clear, Safe, and Compliant Labeling. EU MDR, FDA & CDSCO Labeling Regulation.

Per Annex I, Chapter III of the EU MDR and EU IVDR, the information supplied by the manufacturer should take the form of internationally recognized symbols, where appropriate. These symbols “must conform to the harmonised standards or common specifications” (EU MDR Annex I, Chapter III (23.1h) and EU IVDR Annex I, Chapter III (20.1h)).

New Symbols Required by EU MDR and IVDR. The new EU MDR and IVDR introduce several new symbols that medical device manufacturers must use on their products to comply with the regulations. These symbols include: