Since December 28, 2022, Pixacare Application has carried the CE marking. Based on a self-declaration of conformity, this marking reflects Pixacare's commitment to designing and evolving its solution in compliance with the European regulatory framework applicable to medical devices.
What is the CE marking for a medical device?
The CE marking harmonizes European technical legislation and is a prerequisite for placing any medical device on the market within the European Union.
What it requires from the manufacturer
To affix this marking, the manufacturer must compile technical documentation demonstrating that the product meets the safety and performance requirements defined by European regulation 2017/745. This process engages the manufacturer's responsibility across the entire product lifecycle.
A commitment to quality and compliance
The CE marking of Pixacare Application structures the company's quality approach and strengthens the confidence of healthcare facilities in the solution. It reflects Pixacare's ability to meet European regulatory requirements, while continuing to develop its features in the service of clinical teams.
Références
- Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR). Official Journal of the European Union.
- European Commission. The CE marking. ec.europa.eu.
