The EU reg­u­la­to­ry envi­ron­ment still sees the release of numer­ous guid­ance doc­u­ments that may help eco­nom­ic oper­a­tors to imple­ment the require­ments for Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices or in vit­ro diag­nos­tic med­ical devices respec­tive­ly (MDR and IVDR):


The Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished MDCG 2023-3, Ques­tions and Answers on vig­i­lance terms and con­cepts as out­lined in the Reg­u­la­tion (EU) 2017/745 on med­ical devices. The doc­u­ment pro­vides spe­cif­ic advice on how man­u­fac­tur­ers should set up their vig­i­lance sys­tem and can be seen as a replace­ment of MEDDEV 2.12-1. Mdi Europa is cur­rent­ly work­ing on a more com­pre­hen­sive arti­cle on that top­ic. Please note the guid­ance address­es the MDR require­ments. An update is expect­ed for the IVDR. We nonethe­less think that the doc­u­ment may gen­er­al­ly be very use­ful also for man­u­fac­tur­ers of IVD med­ical devices.


Noti­fied body bsi pub­lished a white paper on dos and don’ts under the IVDR. It is an update to the pre­vi­ous­ly issued doc­u­ment and pro­vides a check­list approach to the dif­fer­ent aspects for a suc­cess­ful IVDR implementation.

The noti­fied body asso­ci­a­tion Team-NB pub­lished a best prac­tice guid­ance for tech­ni­cal doc­u­men­ta­tion sub­mis­sions accord­ing to annex II and III of the IVDR. Although the mar­ket seems to see the guid­ance in parts crit­i­cal, we think it is a valu­able sup­port to pre­pare tech­ni­cal files in accor­dance with IVDR require­ments. It can also be a use­ful tool for man­u­fac­tur­ers of class A IVD med­ical devices where no noti­fied body involve­ment is required as the posi­tion of noti­fied bod­ies and com­pe­tent author­i­ties are often aligned.

The med­ical tech­nol­o­gy indus­try asso­ci­a­tion MedTech Europe issued the third edi­tion of its ebook Clin­i­cal Evi­dence Require­ments under the EU In Vit­ro Diag­nos­tics Reg­u­la­tion (IVDR). The doc­u­ment is a “a col­lec­tion of ques­tions and answers designed to help man­u­fac­tur­ers nav­i­gate their per­for­mance eval­u­a­tion oblig­a­tions under the IVD Reg­u­la­tion 2017/746.”

Should you have any ques­tions or wish to have one of the doc­u­ments sub­mit­ted to you, please let us know.

Source: MDCG, bsi , Team-NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Browse by tag “Guid­ance Doc­u­ments“.