Citieffe has obtained in November 2022 the certification of the products according to the new EU MDR 2017/745 regulation on medical devices that came into force in 2021. A complex activity that required a new certification with the requirements set by the new Regulation for products already certified from 1998 to today, according to the old MDD directive 93/42/EEC.

A record-breaking success, if it is estimated that by the end of October only 8.73% of the current 22,793 certificates due to expire by 2024 had already obtained certification and in 82% of cases certification of both the quality management system (QMS) and the products required a minimum time of 13 months up to 18 for the highest risk classes*.

Citieffe completed the QMS and product certification process in just 9 months.

The quality system certification has also been renewed in compliance with the UNI-EN-ISO 9001:2015 and UNI-EN-ISO 13485:2021 standards.

*Source: European Commission: “Notified Bodies Survey on certifications and applications (MDR/MDCG & Stakeholders)”, 24 Oct 2022

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