The Medical Device Regulation (MDR EU/2017/745) will be fully adopted as of may 26th 2021
Thecofarma Medical Supplies B.V. Will handle this as followed:
- Thecofarma will be fully compliant to the EU Medical Device Regulation.
- Thecofarma is solely a Distributor and NOT a manufacturer or importer
- As of May 26th 2021 Thecofarma 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 dates set in the regulations.
- All products Thecofarma supplies are stored under the conditions set by the manufacturer. We expect from our suppliers, that they will provide all applicable CE-certificates and EU Declarations of Confirmity. If necessary we can provide these, upon specific request, within a reasonable amount of time, if available.
- All incoming products will be registered by Thecofarma with batch/lot or serialnumber. In case of a recall Thecofarma can trace back products by these batch, lot or serial numbers.
- Thecofarma will cooperate with government required sampling.
- If as a result of the MDR certain products will no longer be available, we will inform you as soon as possible.