SQS receives national designation regarding the MDR
SQS fulfils all the requirements needed for certification in accordance with the new Medical Devices Regulation. Swissmedic confirms this with its national designation of 28 January 2021.
The Swiss Association for Quality and Management Systems (SQS) has been working for over two years to achieve this. At the end of January 2021 it now received the formal designation from Swissmedic as a conformity assessment body for medical devices under Regulation (EU) 2017/745.
With its decision, the national authority recognises that SQS meets all the requirements for the application of the new Medical Device Regulation (MDR). The association based in Zollikofen BE has therefore demonstrably done its technical homework. There are no more open points in this regard.