The Med­ical Device Coor­di­na­tion Group (MDCG) has issued a new guid­ance doc­u­ment MDCG 2021-1, Guid­ance on har­monised admin­is­tra­tive prac­tices and alter­na­tive tech­ni­cal solu­tions until  EUDAMED is ful­ly func­tion­al. The doc­u­ment seeks to pro­vide clar­i­fi­ca­tion in a high­ly ambigu­ous sce­nario.

Numer­ous ref­er­ences in Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) are relat­ed to EUDAMED and new and com­pre­hen­sive reg­is­tra­tion procedures.

EUDAMED was planned as a cen­tral and inte­gra­tive tool for increased trans­paren­cy and mar­ket sur­veil­lance under the MDR and IVDR regime. Cur­rent plans pro­vide for a full avail­abil­i­ty of the data­base by May 2022. The actor reg­is­tra­tion mod­ule has been made avail­able in Decem­ber 2020 while the remain­ing five mod­ules will be intro­duced gradually.

This has led to a high degree of con­fu­sion among eco­nom­ic oper­a­tors – uncer­tain­ty exists for exam­ple around ques­tions relat­ed to the dead­lines for man­u­fac­tur­er and device reg­is­tra­tions, but also with regards to the applic­a­bil­i­ty of UDI requirements.

MDCG 2021-1 attempts to give answers at least to some of these ques­tions. For exam­ple, the doc­u­ment says:

We rec­om­mend to review the guid­ance doc­u­ment in addi­tion to read­ing this arti­cle as we have only men­tioned the main aspects. The full doc­u­ment can be found here.

Source: Euro­pean Commission

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