OEM/Private Label­ing was a com­mon con­cept under the AIMDD, MDD and IVDD. Under the MDR and IVDR require­ments are much stricter. Get a quick overview, why your prod­ucts are affect­ed and how you have to proceed. 

The Con­trac­tu­al Oblig­a­tions of Out­sourc­ing Com­pa­nies and Vendors

Recent­ly, mdi Europa has received many ques­tions with regards to OEM or Pri­vate Labelling issues, due to the shift in per­spec­tive from the Active Implantable Med­ical Devices Direc­tive (AIMDD), Med­ical Devices Direc­tive 93/42/EEC (MDD) and In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive (IVDD) to the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR)

While it was com­mon prac­tice under the Direc­tives (AIMDD, MDD, IVDD) to hold only a sim­pli­fied Tech­ni­cal File as an Own Brand Label­er (OBL) or Pri­vate Label­ing Man­u­fac­tur­er (PLM), the rules became stricter under the MDR and IVDR. Already before the date of full appli­ca­tion of the MDR and IVDR, select­ed mem­ber coun­tries, e.g. the UK, tight­ened the cor­re­spond­ing pro­vi­sions in their markets.

Sim­ply said, the MDR and IVDR now make clear that there will be no dif­fer­ence between the OBL and the OEM from a reg­u­la­to­ry point of view:

Arti­cle 10(4) of the MDR and IVDR requires the man­u­fac­tur­er as reflect­ed on the label­ing to hold a com­plete ver­sion of the Tech­ni­cal Doc­u­men­ta­tion as per annex­es II and III. As already men­tioned, this will make the tra­di­tion­al con­cept of Pri­vate Label­ing obsolete.

It goes with­out say­ing that devices requir­ing noti­fied body involve­ment would also oblige the cor­re­spond­ing OBL/ PLM man­u­fac­tur­er to hold its own noti­fied body certificate. 

Arti­cle 16 of the MDR and IVDR pro­vide fur­ther spec­i­fi­ca­tions and sce­nar­ios under which man­u­fac­tur­er oblig­a­tions apply to importers and dis­trib­u­tors. Eco­nom­ic oper­a­tors are thus rec­om­mend­ed to care­ful­ly con­sid­er con­trac­tu­al rela­tion­ships with cus­tomers and partners.

Use the fol­low­ing links to receive addi­tion­al infor­ma­tion on this subject