Only sev­er­al months before the Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) ful­ly applies it is time for pos­i­tive aspects: The MDR con­tains con­struc­tive guid­ance in many cru­cial aspects, one of them being the estab­lish­ment of con­trac­tu­al arrange­ments of eco­nom­ic oper­a­tors who part­ner in device devel­op­ment and man­u­fac­tur­ing. This arti­cle sheds light upon the issue of qual­i­ty assur­ance agree­ments between man­u­fac­tur­ers and their orig­i­nal equip­ment man­u­fac­tur­ers (OEMs).   

Noti­fied Bod­ies (NB) review QAAs in-depth

Reg­u­la­to­ry require­ments will force both par­ties to align their process­es in many areas. One of the out­puts is the QAA. Inter­linked process­es and the con­tracts will be audit­ed by NBs very care­ful­ly, result­ing in count­less non­con­for­mi­ties. QAAs which pass with­out cor­rec­tive actions will save time and money. 

When a QAA is necessary

QAAs should be installed for all crit­i­cal sup­pli­ers and out­sourced crit­i­cal process­es. In all cas­es where the ques­tion: “Who does what?” has to be answered, there should be a detailed QAA.

Three ques­tions out of many: 

  1. Is it real­ly clear to the OEM of a Class III prod­uct that he has to report changes in the spec­i­fi­ca­tion to the man­u­fac­tur­er well in advance, so the man­u­fac­tur­er can com­mu­ni­cate this change to the NB and get approval?
  2. Who is in charge of batch release?
  3. Who is in charge of which part of the tech­ni­cal documentation? 

Need­less to say that this list is not exhaustive.

The QAA as the cen­tral con­trol­ling document

QAAs should reflect the dai­ly life between man­u­fac­tur­ers and OEMs. They need to be very spe­cif­ic. Both par­ties should be able to iden­ti­fy con­trol ele­ments and their indi­vid­ual tasks and imple­ment them into their own pro­ce­dures and process­es. All eco­nom­ic oper­a­tors will be able to design a QAA and use it as an excel­lent instru­ment for dai­ly work, if they take their time and extract all the scat­tered infor­ma­tion hid­den in the new MDR.

This approach – too idealistic?

Is it real­ly too ide­al­is­tic to pre­dict that the strong reg­u­la­tions of the MDR help estab­lish­ing coop­er­a­tion between man­u­fac­tur­ers and their crit­i­cal sup­pli­ers? We believe that pre­cise and detailed QAAs are an excel­lent start for suc­cess­ful cooperation. 

Astra­Con is an estab­lished enter­prise in the reg­u­la­to­ry field since 2013. We pro­vide analy­ses of your tech­ni­cal doc­u­men­ta­tion and QM sys­tem. Our spe­cial­i­ties are estab­lish­ing state of the art clin­i­cal eval­u­a­tions. We know exact­ly how QAAs have to look like to be a true basis for long-term com­mu­ni­ca­tion and trust­ful rela­tion­ship between eco­nom­ic operators. 

We are con­vinced that reg­u­la­tion can be turned into suc­cess. Con­tact us via mdi Europa!

Source: Astra­Con

You might also read our cor­re­spond­ing arti­cle on Pri­vate Label­ing (OEM)