The new Medical Device Regulation law (MDR EU 2017/745) will come into effect from May 26, 2021.
How does Medical2Day BV deal with the MDR scheme?
According to the MDR, Medical2Day BV is exclusively a distributor and not a manufacturer or importer. We declare that as of May 26, 2021, all items supplied by us have been checked and meet the requirements set out in Article 14 of the MDR EU 2017/745 regulation.
From May 26, 2021, Medical2Day BV will only supply medical devices that comply with the MDR or, where regulations allow a longer transition period, comply with the current MDD until they comply with the MDR on the dates set in the regulations.
We are aware that due to the enormous pressure at the appointed authorities, not all products will have a CE mark and/or EU declaration of conformity in time.
If we cannot find a suitable solution within the framework of the legislation, we will offer an alternative product in consultation with the customer. If certain items are no longer available as a result of the MDR, we will inform you as soon as possible.
CE certificates and EU declarations of conformity
Medical2Day BV expects its suppliers to make all applicable CE certificates and EU declarations of conformity available.
If necessary, Medical2Day BV can provide you with this information within a reasonable period upon specific request, insofar as it is available.
Storage and Distribution
All products supplied by Medical2Day BV are stored according to the conditions prescribed by the manufacturer. In the event of a recall, Medical2Day BV can trace products based on batch, lot or serial number.
In the event of deviations and incidents noted by the customer, we would like to receive a notification with at least the UDI, the item description and a detailed description of the complaint to our general email address [email protected]
If you have any questions about how we handle the MDR, please send an email with your details and ask to [email protected]