The first mod­ule of the EU med­ical device data­base, EUDAMED, is up and run­ning. How­ev­er, because actor reg­is­tra­tion is vol­un­tary until 26 May 2022, when the com­plete data­base is planned to be ready, mem­ber states can call for actor reg­is­tra­tion on a nation­al basis under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR).

The launch means that since 1 Decem­ber, 2020, man­u­fac­tur­ers and oth­er eco­nom­ic oper­a­tors can obtain a Sin­gle Reg­is­tra­tion Num­ber (SRN) and reg­is­ter on a vol­un­tary basis in the data­base. Dis­trib­u­tors are not oblig­ed to register. 

It is, how­ev­er, feared that for increased mar­ket sur­veil­lance, some coun­tries could demand man­u­fac­tur­ers to reg­is­ter them­selves local­ly under the MDR from 26 May 2021 – when the Reg­u­la­tion ful­ly applies – until 26 May 2022 or longer, when EUDAMED becomes ful­ly oper­a­tional. After that time, infor­ma­tion would have to be legal­ly includ­ed in the EUDAMED data­base and made avail­able to all author­i­ties around the EU. 

This, of course, is an unwant­ed sce­nario, which is why the Euro­pean Com­mis­sion has asked EU com­pe­tent author­i­ties to adver­tise the process as com­pli­ant and try to pre­vent dou­ble reg­is­tra­tion at a nation­al lev­el. All eco­nom­ic oper­a­tors are advised to reg­is­ter with EUDAMED prompt­ly to avoid any pos­si­ble holdups in con­firm­ing their EUDAMED reg­is­tra­tion by their nation­al com­pe­tent author­i­ty. Still, cer­tain mem­ber states seem to see poten­tial issues in that regard. Ger­many, for exam­ple, has put the assign­ment of SRNs on hold for the time being. 

The EUDAMED actor reg­is­tra­tion mod­ule went live on 1 Decem­ber 2020 and is the first of the EUDAMED to be made avail­able. The mod­ules below are yet to be published:

Sources: Medtech Insight (an Infor­ma prod­uct), Euro­pean Commission

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