As of 26 May 2021 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 2021.
- According to the MDR, DSN Trade is solely a Distributor and not a manufacturer or importer.
- DSN Trade declares that as of 26 May 2021 all items it supplies have been checked by representative sampling and are compliant to the obligations described in article 14 of the regulation MDR EU 2017/745.
- As of 26 May 2021 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 on time. 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.
- DSN Trade expects from its suppliers that they will provide all applicable CE-certificates and EU Declarations of Conformity. If necessary DSN Trade can provide these, upon specific request, within a reasonable amount of time, if available.
- 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.