CE marking provides a unified framework for technical legislation across European member states. To obtain it, manufacturers must produce comprehensive technical documentation demonstrating that their product meets the safety and performance requirements set out in European Regulation 2017/745 on medical devices.
Placing a medical device on the EU market requires CE marking. For Pixacare, this certification is not a formality — it is a concrete commitment to every institution, clinician and patient that uses the platform.
What Pixacare does
Pixacare automates the classification of medical photographs by date and patient, and secures their storage. The solution was built to address a real and widespread clinical need: healthcare professionals routinely take medical photographs on personal smartphones, with no structured or secure framework to manage them.
Beyond photograph management, Pixacare includes a dedicated wound documentation module for chronic and surgical wounds. Photographs, measurements and clinical data are recorded directly in the patient file within the application, enabling teams to track wound progression over time.
Through its remote monitoring and secure messaging features, hospital clinicians can also follow healing progress remotely, in close collaboration with community nurses.
CE marking since 28 December 2022
Pixacare has held CE marking as a medical device since 28 December 2022, a recognition that the platform meets the highest European standards for safety, performance and data integrity.
