Medical Device Regulation (MDR)

The 'Medical Device Regulation' will come into effect from May 26, 2021. This regulation sets stricter requirements for medical devices. Manufacturers, wholesalers, distributors, but also online stores must comply with this. On this page you will find how Carestores BV – the company behind diabetesmagazijn.nl – deals with this.

What is the MDR?

MDR (Medical Device Regulation) is the new Medical Device Regulation, which replaces the former MDD (Medical Device Directive) in Europe. From a directive to binding requirements. This leaves less room for interpretation between the different EU member states. The MDR is a European regulation. The MDR places higher demands on the safety and reliability of medical devices.

What are we?

Carestores BV is exclusively a distributor according to the MDR. We are not a manufacturer, importer or wholesaler. We supply products that are intended for the end user. We do not change products or packaging. Labeling is as a manufacturer or wholesaler has placed it. The products offered meet the requirements set out in Article 14 of the MDR EU 2017/745 regulation. In the event of a transition period, the manufacturer promises to Carestores BV that the product will comply with the MDR when this transition period has expired.

CE mark

Carestores BV has agreed with manufacturers and suppliers that declarations of conformity, technical documentation and CE certificates can be made available upon request. Manufacturers guarantee that they have the necessary documents. Carestores BV carries out its own checks to ensure that products have CE marking and correct package leaflets. We also pay attention to the language of the package leaflet.

Storage and transportation

Carestores BV ensures correct storage and transport conditions of the products offered. The warehouse has 'climate controlled' rooms with which the temperature can be regulated in the event of extreme heat or cold. In the event of a recall, users can be traced based on their order history, after which the warning about the product in question can be sent by email or post.

If you have any questions about our dealings with the MDR, please contact us at info@carestores.nl.