The Euro­pean Com­mis­sion wants to per­mit ear­ly access to SRN before Eudamed launch­es in 2022

Eudamed will be delayed by at least two years. How­ev­er, upon pres­sure by local coun­try author­i­ties, the Euro­pean Com­mis­sion wants to per­mit ear­ly access to SRN before Eudamed launch­es in 2022 to tem­porar­i­ly facil­i­tate vol­un­tary reg­is­tra­tion. Eco­nom­ic oper­a­tors can decide if they want to reg­is­ter in Eudamed’s new actor reg­is­tra­tion mod­ule, which should be avail­able by 26 May 2020. The aim is to har­monise reg­is­ter pro­ce­dures as soon as pos­si­ble in light of the delay in launch­ing the Eudamed 3 database.

The SRN is a code for instant recog­ni­tion of every eco­nom­ic oper­a­tor in the EU. It seems that some EU mem­ber states are cur­rent­ly assess­ing to what degree they can use the SRNs in their nation­al sys­tems short-term. 

In keep­ing with the Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR), man­u­fac­tur­ers have to apply for the SRN no lat­er than six months after notice is pub­lished in the OJEU declar­ing that Eudamed is ful­ly oper­a­tional. That dead­line is cur­rent­ly like­ly to be 26 Novem­ber 2022. How­ev­er, the MDR will be ful­ly imple­ment­ed on time on 26 May 2020, with­out Eudamed. It is under­stood that the Com­mis­sion is prepar­ing a guid­ance to explain the prac­ti­cal sides of the post­pone­ment of Eudamed 3. 

Source: Medtech Insight (an Infor­ma product)

We rec­om­mend the fol­low­ing sources for in depth information

Our arti­cle “News on EUDAMED“.
Our arti­cle “Device Reg­is­tra­tion and Lega­cy Devices“.