harmonized standards Tag

Harmonized Standards:

The Summary of the references of the harmonized European standards was published in the Official Journal of the European Union, in support of Regulation (EU) 2017/745 on medical devices and of Regulation (EU) 2017/746 on medical devices in vitro. New Commission Implementing Decision (EU) 2023/1410 has been released amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products (EN ISO 25424:2019) and biological evaluation of medical devices (EN ISO 10993-10:2023).


For more information: https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en


Unique Device Identifiers for contact lenses:

The EU Commission has published a Delegated Regulation amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses.

In order to resolve implementation issue and allow a proportionate UDI-DI (the identifier specific to a manufacturer and a device) data entries in Eudamed, the “Master UDI-DI” has been developed by the Commission. Master UDI-DI is intended as the identifier of a group of highly individualised devices (i.e. contact lenses) presenting specific similarities with respect to defined clinically relevant parameters. In the future the Master UDI-DI solution could be extended to a other highly individualised devices.


For more information: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=PI_COM:Ares(2023)2068096&utm_source=QualityMedDev&utm_campaign=6251345263-EMAIL_CAMPAIGN_2021_09_05_08_08_COPY_01&utm_medium=email&utm_term=0_7b44d626e2-6251345263-233168890&mc_cid=6251345263&mc_eid=f01fefd851