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MDR documentation - EMEA

Distributors/dealers are important market players in the chain between the manufacturer and patients. The implementation of the Medical Device Regulation (MDR (EU) 2017/745) defines the requirements on the Economical operators (includes distributor and dealers of medical device). The distributors/Dealers now have to verify that the medical devices they sell meet the defined requirements as outlined in Art. 14 of the MDR.

Among other things, distributors must check whether the medical devices are CE-marked and have a valid declaration of conformity. To facilitate that task this page contain the valid version of the Permobil product line as well as products distributed by Permobil.