Q&A on arti­cle 10 of the MDR and IVDR

In our Novem­ber newslet­ter, we have report­ed that the Com­mis­sion pub­lished a Q&A doc­u­ment on arti­cle 10a of Reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR) on the oblig­a­tion of eco­nom­ic oper­a­tors to alert com­pe­tent author­i­ties and the mar­ket in the case of inter­rup­tion or dis­con­tin­u­a­tion of the sup­ply chain for cer­tain devices. Revi­sion 1 from Decem­ber 2024, pro­vides updates to cer­tain foot­notes. You can down­load the doc­u­ment from our library section.

MDCG 2022-3

The Med­ical Device Coor­di­na­tion Group (MDCG) updat­ed its guid­ance doc­u­ment on Ver­i­fi­ca­tion of man­u­fac­tured class D IVDs by noti­fied bod­ies. The over­all pur­pose of the doc­u­ment was to pro­vide “[…] best prac­tices for noti­fied bod­ies in per­form­ing con­for­mi­ty assess­ment pro­ce­dures relat­ing to the ver­i­fi­ca­tion of man­u­fac­tured class D IVDs.” The lat­ter is required in the con­text of batch test­ing for class D IVD med­ical devices under the IVDR. Revi­sion 1 now includes a num­ber of edi­to­r­i­al and clar­i­fi­ca­tion changes that are list­ed on page 2 of the doc­u­ment. You can down­load the doc­u­ment here. 

MDCG 2023-3

Rather short­ly after its first revi­sion in Octo­ber last year, the MDCG has pub­lished the sec­ond revi­sion of MDCG 2023-3, Ques­tions and Answers on vig­i­lance terms and con­cepts as out­lined in the Reg­u­la­tion (EU) 2017/745 and Reg­u­la­tion (EU) 2017/746. As the tile says, the doc­u­ment works as a guid­ance on how to han­dle vig­i­lance relat­ed ques­tions under the MDR and IVDR. This update pro­vides minor edi­to­r­i­al notes and cor­rec­tions. You can down­load the doc­u­ment from our library section.

TEAM-NB guid­ance on the MDR cer­ti­fi­ca­tion process

Noti­fied body asso­ci­a­tion TEAM-NB set up a posi­tion paper on the MDR cer­ti­fi­ca­tion process includ­ing pre-appli­ca­tion, appli­ca­tion and post-appli­ca­tion phas­es. The doc­u­ment is use­ful for all eco­nom­ic oper­a­tors to under­stand as it sheds light on the com­plex cer­ti­fi­ca­tion process under the MDR. The doc­u­ment may be down­loaded here.

Source: Euro­pean Com­mis­sion, TEAM-NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Browse by tag “Guid­ance Documents”