The require­ments under the Med­ical Devices Direc­tive and In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive (93/42/EEC, MDD and 98/79/EC, IVDD) for the set-up of tech­ni­cal files were very gen­er­al in nature.

The Med­ical Devices Reg­u­la­tion and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (2017/745, MDR and 2017/746, IVDR) are much more spe­cif­ic in this regard. Annex­es II and III of the Reg­u­la­tions give an overview of the required con­tents and may also be used as a top-lev­el struc­ture of the tech­ni­cal doc­u­men­ta­tion. Alter­na­tive for­mats, e.g. STED may be used, but the sug­gest­ed con­tents must be included.

Please be aware that review­ers are oblig­ed to not accept tech­ni­cal files that do not ful­fill the require­ments men­tioned above.

Fur­ther­more, both Reg­u­la­tions say that the tech­ni­cal file “shall be pre­sent­ed in a clear, organ­ised, read­i­ly search­able and unam­bigu­ous man­ner” (MDR and IVDR, annex II).

Should you have any ques­tions, please don’t hes­i­tate to get in touch with our team.

Sources: MDR, IVDR

For fur­ther in depth infor­ma­tion on changes accom­pa­ny­ing the new reg­u­la­tions, we warm­ly rec­om­mend fol­low­ing arti­cles and pages

Tech­ni­cal Doc­u­men­ta­tion Require­ments under the MDR – a Case Study
Sup­port­ive Infor­ma­tion Sec­tion MDR/IVDR
Major Aspects of the MDR
Major Aspects of the IVDR