Today marks an important milestone for SocialDiabetes and, most importantly, for all the patients, healthcare professionals, and organizations with whom we share the ambition to transform diabetes management through safe, effective, and validated technology.
After successfully passing all regulatory audits, we are proud to announce that SocialDiabetes has officially obtained certification under the European Medical Device Regulation (MDR) in Class IIB for all our products.
What does this certification mean?
Regulation (EU) 2017/745, known as the MDR, is the most stringent regulatory framework in the world for medical devices. Its goal is to ensure the highest levels of safety and efficacy for patients in an increasingly complex and technologically advanced environment.
The Class IIB certification recognizes SocialDiabetes as a clinical intervention solution with a direct impact on patient health. This classification applies to products that, like ours, influence critical therapeutic decisions such as insulin administration, glucose monitoring, and treatment adherence management.
This certification not only validates our processes, algorithms, and technological architecture—it reinforces our commitment to:
- The clinical and technological safety of our users
- The robustness and transparency of our data traceability
- Interoperability with medical devices and healthcare systems
- The ability to scale internationally while meeting the most demanding regulatory standards
This certification not only endorses the safety and effectiveness of our solution, but also strengthens its suitability for value-based purchasing models, which are increasingly shaping our industry partners’ market access strategies. Having a Class IIB MDR-certified product facilitates its inclusion in settings where health outcomes and economic efficiency are prioritized.
Thank you, Asphalion
We want to express our sincere gratitude to Asphalion, the regulatory consultancy that has brilliantly guided us through this entire process. Their expertise, rigor, and commitment were key to achieving this milestone. They were much more than consultants—they were true allies on a challenging but essential journey to ensure our technology meets the highest European standards.
At SocialDiabetes, we have spent over a decade working to make technology a real tool for empowerment, personalization, and prevention. And we will continue to do so—now with the reassurance of having the regulatory endorsement to support it.
This milestone positions us as one of the few digital diabetes management platforms with this regulatory category in Europe. At the same time, it is a starting point to open new opportunities for collaboration with a healthcare ecosystem that increasingly embraces digitally-enabled, clinically safe, and sustainable solutions.
Thank you to the entire team who made this possible.
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