The dealers have a duty
A number of medical products would not make it onto the market if they did not exist: The dealers . They are an essential part of the supply chain. They form the bridge between medical technology companies and users. How often have good and innovative products been developed that meet the nerve and needs of the market but never get there? The main tasks of dealers and sales partners are clear: procurement, marketing and sales including storage and transport . Activities such as instruction, installation, maintenance or repairs may also be added.
However, with the EU Medical Device Regulation (MDR) 2017/745, dealers and distributors of medical products are given additional functions and tasks that they are not necessarily able to cope with with previous know-how. Whether wholesalers, middlemen or retailers, the MDR makes no distinction. Every legal or natural person who purchases, owns and (re) markets medical devices or makes them available on the market is referred to as a so-called dealer. This should now also act as a kind of supervisory authority. In addition, they are more committed to storage, traceability and vigilance.
However, if you take a detailed look at Union law, it becomes clear that the MDR largely takes up what was already introduced for economic actors in 2008.
"N ew" obligations for traders n of medical devices?
The provisions were actually derived from Regulation (EC) No. 765/2008, Decision No. 768/2008 / EC and the guidelines for implementing EU product regulations (Blue Guide). These have also been taken into account by the EU member states in their legislation. For dealers, however, these obligations only really come into play with the start of the MDR. This is also one of the motives of the European Parliament and the Council to write down these requirements in the MDR (motive 27). Economic actors should “better understand the set obligations and thus better comply with the regulatory provisions”.
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