Final­ly, dou­ble digits! The num­ber of noti­fied bodies accre­di­ted under the MDR clim­bs to 11

All noti­fied bodies accre­di­ted under the pre­vious legal regime (MDD/AIMDD) will lose their sta­tus once the MDR takes effect on 26 May 2020 and will have to be reac­cre­di­ted in accordance with the MDR as of that date. Still, a 11th noti­fied body has now been accre­di­ted under the MDR: DNV GL Pre­safe AS in Nor­way, an EFTA sta­te (Nan­do data­ba­se). The low num­ber of noti­fied bodies con­ti­nues to be a bot­t­len­eck for medi­cal device manu­fac­tu­r­ers in navi­ga­ting the con­for­mi­ty assess­ment pro­ce­du­re and brin­ging inno­va­ti­ve medi­cal devices to mar­ket. Exten­ded tran­si­tio­nal peri­ods for cer­tain devices do litt­le to chan­ge this fact.


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