MDR, IVDR, re-cert ISO 13485

Medi­cal device manu­fac­tu­r­ers to face chal­lenges in 2019 too!

In 2018, an initi­al cour­se was plot­ted by many medi­cal device manu­fac­tu­r­ers on the long road to MDR com­pli­ance. In 2019 it will be important for them to car­ry on reso­lut­e­ly along that road, adap­ting both their own orga­ni­sa­ti­on and their coope­ra­ti­on with deve­lo­p­ment part­ners, sup­pli­ers and dis­tri­bu­tors, and also noti­fied bodies, to the new Euro­pean regu­la­ti­ons in order to achie­ve MDR com­pli­ance. This in spi­te of the fact that many ques­ti­ons thrown up by the MDR and IVDR have still not been resol­ved, in spi­te of the fact that essen­ti­al ins­tances such as the Euda­med data­ba­se – on which manu­fac­tu­r­ers have no influence – are still not func­tio­ning pro­per­ly, and in spi­te of the fact that a con­sidera­ble num­ber of noti­fied bodies have so far not even made an appli­ca­ti­on for accre­di­ta­ti­on under the MDR / IVDR. From that point of view, it is to be hoped that the year 2019 will at least bring cla­ri­ty in some cases.

It’s not as if the chal­lenges refer­red to abo­ve only affect ‘clas­si­cal’ device manu­fac­tu­r­ers. Incre­asing­ly, the pro­ducts them­sel­ves are inter­con­nec­ted with data­ba­ses of health­ca­re pro­fes­sio­nals, pro­vi­ders of main­ten­an­ce ser­vices or pati­ents’ devices, or their appli­ca­ti­on is sup­port­ed by accom­pany­ing apps. Soft­ware may be qua­li­fia­ble and clas­si­fia­ble as a medi­cal device within the mea­ning of the MDR. The requi­re­ments rela­ting to the (cyber-)security of digi­tal pro­ducts should not be underestimated.

Tog­e­ther with the recer­ti­fi­ca­ti­on of their qua­li­ty manage­ment sche­me in accordance with DIN ISO 13485:2016, which must be fina­li­sed in 2019, manu­fac­tu­r­ers – of ana­lo­gue and digi­tal pro­ducts – can only be encou­ra­ged and sup­port­ed in their (con­tin­ued) imple­men­ta­ti­on of the requi­re­ments of the MDR / IVDR rela­ting to qua­li­ty manage­ment. It is important to focus careful­ly here on the con­fi­gu­ra­ti­on of the risk manage­ment sys­tem and the imple­men­ta­ti­on of cli­ni­cal assess­ments and cli­ni­cal tri­als. The aim pur­sued with the MDR / IVDR, that of mini­mi­sing the risks posed by medi­cal devices to pati­ents and users, also demands opti­mi­sed sup­pli­er manage­ment from manu­fac­tu­r­ers, and clo­ser coope­ra­ti­on with dis­tri­bu­tors too. It is a mat­ter of being able to retrace the enti­re life cycle of the pro­duct all the way through into the sup­p­ly chain, from the pro­vi­der of deve­lo­p­ment ser­vices on the one hand to the end user on the other, so that, when all is said and done, strin­gent con­trac­tu­al con­trol of the inter­ac­tion of the eco­no­mic ope­ra­tors is necessary.