MDCG guid­ance on admin­is­tra­tive prac­tices and tech­ni­cal alter­na­tives until EUDAMED full functionality

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:

• Inde­pen­dent­ly from the delay of device reg­is­tra­tion require­ments, the over­all UDI require­ments apply for all man­u­fac­tur­ers who aim to declare com­pli­ance to the MDR as of May 26, 2021. 
• For class III and implantable devices the Sum­ma­ry of Safe­ty and Per­for­mance shall be made avail­able to the pub­lic upon request or man­u­fac­tur­ers should spec­i­fy where the sum­ma­ry is made available.
• Peri­od­ic Safe­ty Update Reports set up by man­u­fac­tur­ers of class III or implantable devices should deliv­er the reports to the Noti­fied Body by appro­pri­ate means.
• Seri­ous inci­dent report­ing should be done to the respec­tive nation­al com­pe­tent author­i­ties with the new MIR form. FSCAs includ­ing FSNs, PSRs and trend reports should use the cur­rent form with addi­tion­al infor­ma­tion as required by the MDR added in the report. All items will have to be pro­vid­ed to the con­cern­ing nation­al com­pe­tent authorities.

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

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing arti­cles and con­tent on our website

• Vol­un­tary reg­is­tra­tion with EUDAMED data­base – indus­try fears dupli­cate registrations
• New web­site on actor reg­is­tra­tion in EUDAMED 3 available
• Device Reg­is­tra­tion and Lega­cy Devices