The long over­due guid­ance on qual­i­ty expec­ta­tions for reg­u­la­to­ry fil­ings in the EU con­cern­ing inte­gral and oth­er kinds of drug-device com­bi­na­tion (DDC) is avail­able in draft form for pub­lic consultation. 

It was released by the Euro­pean Med­i­cines Agency (EMA) and advis­es on what infor­ma­tion drug-mak­ers have to present about the med­ical device com­po­nent of their prod­uct as part of an ini­tial mar­ket­ing autho­riza­tion appli­ca­tion (MAA) and after­wards dur­ing the prod­uct life cycle. It cov­ers devices that can be inte­gral to the drug, co-pack­aged or referred to in the medicine’s prod­uct infor­ma­tion but attained separately. 

Com­pa­nies mak­ing drugs with an inte­gral device com­po­nent like pre­filled syringes and auto-injec­tors have been eager­ly await­ing the doc­u­ment as it deals with the new oblig­a­tions in Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR), specif­i­cal­ly arti­cle 117 which requires MAAs to include a CE cer­ti­fi­ca­tion or Dec­la­ra­tion of Con­for­mi­ty for the device, or in some cas­es, an opin­ion from a Euro­pean Noti­fied Body (NB) on the con­for­mi­ty of the device.

The guid­ance describes the sort of data that should be includ­ed in the NB’s opin­ion on the con­for­mi­ty of the device and the EU’s rel­e­vant Gen­er­al Safe­ty and Per­for­mance Requirements.

The EMA released the first in a planned series of guid­ance doc­u­ments some months ago to help com­pa­nies com­ply. The guid­ance describes the sort of data that should be includ­ed in the NB’s opin­ion on the con­for­mi­ty of the device and the EU’s rel­e­vant Gen­er­al Safe­ty and Per­for­mance Require­ments. It should boost trans­paren­cy and con­sis­ten­cy of infor­ma­tion in reg­u­la­to­ry sub­mis­sions, lessen the work­load for all con­cerned and improve patient safety.

Com­ments on the draft guid­ance should be giv­en before August 31. The EMA will take all the com­ments into con­sid­er­a­tion so that the guide­line will be finalised before the MDR ful­ly applies next May.

Source: Medtech Insight (an Infor­ma product)