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. An important milestone on the way to the desired EU notification has thus been reached – the final hurdles are of political nature.
The Swiss Association for Quality and Management Systems (SQS) has been working for over two years to achieve this. Last week 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. From the milestone reached, it is now only a few steps to the desired European designation. SQS has turned into the home straight, the entry as Notified Body in the all-important Nando database according to 2017/745 is within reach.
On 26 May 2021, both the European MDR and the corresponding Swiss Medical Devices Regulation (MepV) will enter into force. Whether Switzerland and the EU will agree on updating the mutual recognition agreement (MRA) or on a transitional solution before this date is a question of political will. SQS continues to be committed to the discussion and remains confident that both parties will ultimately come together in a solution-oriented manner.