Certified
quality
D.M.G. Italia operates in full compliance with European regulations on medical devices, ensuring compliance with the MDR Regulation and ISO international standards, to protect the safety, efficacy and reliability of products.
Quality Certified
D.M.G. ITALIA is a certified company specializing in the design, development, and sale of medical devices and food supplements.
Innovation, Quality
and Compliance
D.M.G. ITALIA is characterized by the specialization of its key Departments.
Research and Development Department characterized by constant innovative capacity.
Regulatory Department, aimed at obtaining and maintaining the certification of Medical Devices according to European regulations.
Quality Assurance Department, able to measure and ensure that the high standards required are always met.
Medical Department, which constantly takes care of products from the Research and Development phase until their market release.
The new Medical Device Regulation (MDR) 2017/745, which replaces Directive (MDD) 93/42/EEC, entered into force on May 25, 2017, and has been fully applicable since May 26, 2021. New medical devices placed on the market must comply with the MDR requirements, while D.M.G. ITALIA medical devices previously certified under the Directive may continue to be placed on the market thanks to the extension of the validity of their Certificates. This extension varies according to the device risk class:
- a) December 31, 2027, for all Class III devices and Class IIb implantable devices, except for specific cases;
- b) December 31, 2028, for Class IIb devices other than those referred to in point a) of this paragraph, for Class IIa devices, and for Class I devices placed on the market in sterile condition or with a measuring function.
The above information is provided for informational purposes only and reflects the current state of European legislation (EU Regulation 2017/745 and subsequent updates, including EU Regulation 2023/607) as of the date of publication. Given the continuous evolution of the regulatory framework for Medical Devices, this content is subject to change in accordance with new legislative provisions. D.M.G. ITALIA, as Legal Manufacturer, ensures the compliance of its Medical Devices in accordance with both the Directive and the European Regulation.
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