Independent termination as Notified Body for MDR (Medical Device Regulation EU 2017/745) per 31st of October 2019

On behalf of the European Commission, Notified Bodies for medical devices are subject to Joint Assessments with the aim of verifying the competence of Notified Bodies in accordance with the current Medical Device Regulation MDR 2017/745. QS ZÜRICH AG has applied to the EU for the MDR. In December 2018, QS ZÜRICH AG carried out a Joint Assessment with Swissmedic and the European Commission regarding the new MDR (Medical Device Regulation EU 2017/745).

The deviations resulting from the Joint Assessment should be rectified. Unfortunately, QS ZÜRICH AG was forced to conclude that it was only possible to handle the deviations with a disproportionately high effort.

The management has therefore decided to abandon the candidacy as Notified Body of the European Union according to MDR EU 2017/745. QS ZÜRICH AG will therefore cease its activities as a Notified Body in this area of
31 October 2019. Customers were informed of this in June 2019.

The certification according to ISO 13485 quality management without product is not affected by this decision.