In accordance with the requirements of the new European Union MDR 745/2017 for medical devices and IVDR 746/2017 for in vitro medical devices and specifically in accordance with articles 30, 31 and 33, all manufacturers, authorized representatives and importers they should be registered in the European database for medical devices, EUDAMED.
UNIHELP’s knowledgeable staff undertakes the specialized registration process responsibly and promptly until obtaining your company’s unique SRN (Single Registration Number).
The whole process is new, time-consuming and requires the collection of several documents.
UNIHELP, always remaining helpful in the development of your company, while following the new data of the European Union, frees you from time and labor costs by fully taking over all the registration phases, the gathering of all the necessary legalizing documents, as well as the communication with EUDAMED or the EOF, where deemed necessary.
experience and expertize in medical devices certifications
Be informed responsibly about the latest developments
Provision of consulting services to businesses and organizations in accordance with the increased requirements of EU regulations.
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