As of 26 May 2020 the Medical Device Regulation (MDR EU/2017/745) will be fully adopted. On this page we explain how DSN Trade will handle this.
- DSN Trade as a company will be fully compliant to the EU Medical Device Regulation (MDR) as of 26 May 2020.
- According to the MDR, DSN Trade is solely a Distributor and not a manufacturer or importer.
- As of 26 May 2020 DSN Trade will exclusively supply medical devices that comply to the MDR or, where the regulations allow for a longer transition period, are still compliant with the MDD until they reach compliance with the MDR by the dates set in the regulations.
We are aware of the pressure on the Notified Bodies, which will result in not all products having a CE mark or EU Declaration of Conformity. If we can not find a suitable solution within the framework of the regulation, we will offer an alternative product.
- If as a result of the MDR certain products will no longer be available, we will inform you as soon as possible.
- We expect from our suppliers (manufacturers and importers) that they will enter all their products in Eudamed as soon as possible. For product details, such as CE certificates and declarations of conformity, we refer to Eudamed.
- All products DSN Trade supplies are stored under the conditions set by the manufacturer.
- In case of a recall DSN Trade can trace back products by batch, lot or serial number.
- DSN Trade will cooperate with government required sampling.