Sirma Medical Systems is glad to announce, that the Diabetes: M platform has acquired CE certification. Diabetes: M and all additional modules are developed in accordance with the requirements of EU Directive 93/42/ЕЕС and are registered in accordance to EU Regulation 2017/745 as a Group of medical devices, Class I by the Bulgarian Drug Agency.
Combined with ISO 13485, this is yet another confirmation that the popular diabetes management system is fully compliant with the highest standards and international regulations for software as medical device development.
ABOUT THE REGULATION
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use.
The Medical Device Directive (Council Directive 93/42/EEC concerning medical devices, is intended to harmonize the laws relating to medical devices within the European Union. The CE mark confirms that the medical device meets certain “essential requirements” of the European General Medical Devices Directive (i.e. that it is fit and safe for the intended purpose). It also shows that the medical device can be freely marketed anywhere in the EEA without further control.
