Qtec Eurep GMBH

european authorized representative we are a strategic partner for non-eu manufacturers of medical devices, who want to start or continue selling their products in the eu, one of the largest economies in the world. ★★ your need ★★ in order to sell products, you as a manufacturer have comply with the requirements as laid out in the ‘medical device regulation’ (eu) 2017/745 or the ‘in-vitro diagnostics regulation’ (eu) 2017/746. one of thes requirements is to designate an authorised representative in order to access the european market. we are an ‘authorized representative’ as required per article 11 in both regulation (eu) 2017/745 and (eu) 2017/746. ★★ what drives us ★★ the well-being of the patient is our top priority. it fulfills us that with the help of our work, your products will be made available for patients safely, effectively and in time. even if we do not develop, manufacture or sell medical devices ourselves, we are experts in the field of ‘medical devices’ as we const