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Following the designation as Notified Body No. 1282 for the European Medical Device Regulation 2017/745 (MDR), Ente Certificazione Macchine has fully implemented its EU conformity assessment activities to ensure continuity in medical device certification for the healthcare sector.
Withings is the first company certified by ECM under the requirements of the MDR regulation. Specifically, the Class IIa devices certified by ECM in accordance with Regulation (EU) 2017/745 include two smart scales for body measurement and scanning and an ECG monitor.
“We are very proud that Withings, a long-standing client that had already certified several devices with us under the MDD, has achieved this important result, attesting to the quality of its products” explains Eng. Diego Stevanella – Sales Manager at ECM. “The trust given by the French company to ECM in the conformity assessment of its medical devices spurs us to work even harder to ensure a professional and efficient certification service for the medical device industry.”
Withings’ devices were audited by ECM’s Medical Devices Division team, which positively assessed their compliance with MDR requirements and issued the relevant EU certificate.
“The success of this milestone goes exclusively to Withings, which carried out a prompt and exemplary work in implementing the requirements of the MDR, confirming itself as an excellence in the medical device industry,” concludes Stevanella.
Withings will now be able to deliver its devices in the European market, fully compliant with current legislation.
Would you like to obtain EU certification to market your medical devices in EU?
Contact us at Eng. Diego Stevanella email@example.com | tel. (+39) 393 2471040
Withings created the first smart scale in 2009, and has been the pioneer in connected health ever since. Its clinically validated and multi-award winning range is used by millions worldwide, and includes smart scales, hybrid watches, blood pressure monitors, sleep analyzers and more. The team of engineers, data scientists, and healthcare professionals at Withings work alongside clinical experts to make it possible to take medical-grade measurements at home. Withings was the first to bring measurements for pulse wave velocity and electrodermal activity into the home – finding ever more precise ways to measure our health. Withings Health Solutions, its dedicated division serving healthcare professionals across chronic disease prevention and management, remote patient monitoring, clinical research and more helps bridge the gap between patients and their care teams.
Withings is dedicated to creating a world where people can see their path to better health, and feel supported to pursue it using devices designed to fit beautifully into daily life, supported by information that unlocks long-term health insights and offers programs to create meaningful change. Find out more at withings.com and connect with us on Facebook, Instagram or Twitter.