Is procurement from outside Switzerland actually allowed?
Yes, as Switzerland has signed up to the European Medical Device Regulation. Products which we procure in Europe comply with all applicable European requirements for placing on the market in accordance with the new Medical Device Regulation, and this also applies for Switzerland. Furthermore, the products are marked in accordance with the Swiss Medical Device Regulations currently in force.
Is procurement from outside Germany actually compliant with MDD/MDR?
Yes, because all medical products that are traded in Europe have been granted a European marketing approval, and are therefore compliant for all European countries. Depending on the risk class, this approval may already have been granted according to the new MDR or, in the case of risk classes I and II, it may still be applied according to the standard Medical Device Directive (MDD), taking into account the applicable transition periods.
Can supply reliability be ensured?
As we can ensure sufficient storage for the product portfolio we have agreed with you, we achieve supply rates of over 98 %. As part of the process, we verify and evaluate your ongoing consumption volumes with you at regular intervals in order to identify any fluctuations at an early stage, and take action as appropriate.
Can batch traceability be ensured?
We regularly carry out screening of our suppliers according to the requirements of the European Medical Devices Regulation. This allows us to ensure that we are only working with safe and compliant suppliers. Seamless batch traceability plays an important role here: our system and our processes are structured in such a way that we can trace any given batch of an item that we have delivered to you right back to the manufacturer in the respective country of origin in Europe.