MDR: Stra­tegy for Manufacturers

Just one year until the MDR takes effect

On 25 May 2017, the medi­cal devices indus­try was sub­jec­ted to an exten­si­ve array of new regu­la­to­ry con­di­ti­ons with the publi­ca­ti­on of Regu­la­ti­on (EU) 2017/745, the MDR Regu­la­ti­on. Even now that two thirds of the three-year tran­si­tio­nal peri­od until the MDR takes effect on 26 May 2020 has expi­red, many ques­ti­ons remain unans­we­red. And pre­vious­ly published “cor­rigen­da” to the text of the MDR do litt­le to cla­ri­fy the key ques­ti­ons sur­roun­ding the Regulation.

The manu­fac­tu­r­ers alo­ne are not in con­trol: they are depen­dent on relia­ble imple­men­ta­ti­on of the struc­tures pro­vi­ded for in the MDR so as to ensu­re that they them­sel­ves and their pro­ducts will be MDR-compliant. Howe­ver, the­re con­ti­nues to be a major snag in this regard.

So far, the Euro­pean Com­mis­si­on has accre­di­ted exact­ly ele­ven noti­fied bodies in accordance with the MDR (as of Febua­ry 2020).  At the same time, the MDR’s new clas­si­fi­ca­ti­on rules mean that a much lar­ger num­ber of pro­ducts than befo­re will have to under­go con­for­mi­ty assess­ment pro­ce­du­res, which have to be over­seen by the noti­fied bodies. For the­se new pro­ducts, 26 May 2020 is a hard dead­line. Even the exten­ded peri­od known as the “sell-out rule,” under which pro­ducts con­forming with the MDD may remain on the mar­ket even after the MDR takes effect, does not app­ly in this case. As a result, it is alre­a­dy clear for many manu­fac­tu­r­ers that suc­cessful MDR cer­ti­fi­ca­ti­on on the effec­ti­ve date will not be pos­si­ble for some products.

Stra­te­gies for manufacturers

Manu­fac­tu­r­ers have no con­trol over exter­nal cir­cum­s­tances, par­ti­cu­lar­ly the ques­ti­on of how quick­ly a rela­ti­onship can be estab­lished with an MDR-accredited noti­fied body. If they have not done so alre­a­dy, it is the­r­e­fo­re important for manu­fac­tu­r­ers to use the last twel­ve months remai­ning befo­re the Regu­la­ti­on takes effect as effec­tively as pos­si­ble and con­sider the aspect of pro­duct life cycle, which is so important for the MDR. Are pro­ducts or pro­duct fami­lies cor­rect­ly clas­si­fied in accordance with the MDR? Can suf­fi­ci­ent cli­ni­cal data be gene­ra­ted? Are the pro­ces­ses for cli­ni­cal assess­ments and tri­als regu­la­ted in grea­ter detail under the MDR than was the case befo­re? How far has plan­ning pro­gres­sed for the UDI and label requi­re­ments which must be adhe­red to when the MDR goes into effect?

Also important: imple­men­ta­ti­on of a risk manage­ment or, at least revie­w­ing the exis­ting risk manage­ment sys­tem, in accordance with the MDR’s requi­re­ments. Right after Artic­le 10(1) of the MDR, which estab­lishes the cen­tral duty for manu­fac­tu­r­ers: ensu­ring that the medi­cal devices they manu­fac­tu­re and mar­ket are MDR-compliant, the requi­re­ment for a risk manage­ment sys­tem can be found in Artic­le 10(2) of the MDR. Manu­fac­tu­r­ers should use the rema­in­der of the tran­si­tio­nal peri­od to adapt their qua­li­ty manage­ment sys­tem so that it con­ta­ins clear risk manage­ment pro­ces­ses which con­form to the MDR, and to ensu­re that the plan­ning, imple­men­ta­ti­on and assess­ment of this sys­tem is docu­men­ted and sup­port­ed by appro­pria­te evi­dence. Qua­li­ty assu­rance for pro­ducts can only be accom­plished by working tog­e­ther with sup­pli­ers and dis­tri­bu­ti­on part­ners. The MDR’s expli­cit­ly sta­ted objec­ti­ve, mini­mi­zing risks to pati­ents and users in con­nec­tion with medi­cal devices, requi­res manu­fac­tu­r­ers to opti­mi­ze their sup­pli­er manage­ment as well as working more clo­se­ly with dis­tri­bu­tors. It is neces­sa­ry to be able to track pro­ducts through their enti­re life cycle, back along the sup­p­ly chain to the deve­lo­p­ment ser­vice pro­vi­der and all the way to the end user on the other side, so that a clo­se con­trac­tu­al arran­ge­ment is requi­red for the inter­ac­tion of eco­no­mic ope­ra­tors. Accor­din­gly, when manu­fac­tu­r­ers con­duct reviews of their qua­li­ty manage­ment sys­tems, they should con­sider how to ensu­re ade­qua­te assess­ment of their sup­pli­ers and dis­tri­bu­ti­on part­ners, as well as ana­ly­zing any stan­dard con­tracts which may exist, par­ti­cu­lar­ly qua­li­ty assu­rance agree­ments, for pro­vi­si­ons requi­ring the con­trac­ting par­ties to coope­ra­ti­on and pro­vi­de infor­ma­ti­on, in light of the need to ensu­re that pro­ducts can be tracked.

Once the MDR takes effect, manu­fac­tu­r­ers (with the excep­ti­on of small and micro-sized enter­pri­ses) will be requi­red in accordance with Artic­le 15 of the MDR to have at least one per­son in their orga­niza­ti­on who will be respon­si­ble for com­pli­ance with regu­la­ti­ons. Accor­din­gly, it is neces­sa­ry to exami­ne befo­re the Regu­la­ti­on takes effect whe­ther such a posi­ti­on can be assi­gned intern­al­ly, whe­ther the­re is a need for trai­ning and whe­ther an exter­nal request for pro­po­sals should be initiated.


Ulti­m­ate­ly, manu­fac­tu­r­ers would be well-advised to use the rema­in­der of the tran­si­tio­nal peri­od prag­ma­ti­cal­ly in order to ensu­re imple­men­ta­ti­on of the requi­re­ments for­mu­la­ted by the MDR. As of now, it remains an open ques­ti­on how indi­vi­du­al requi­re­ments will ulti­m­ate­ly be “expe­ri­en­ced” in prac­ti­ce, in terms of their details and dimen­si­ons, and how spe­ci­fic clau­ses will be “inter­pre­ted” by noti­fied bodies and by the aut­ho­ri­ties. Accor­din­gly, it is advi­sa­ble for manu­fac­tu­r­ers to be able to fur­nish solid expl­ana­ti­ons for the cour­se they take and to docu­ment their cho­sen approach in a struc­tu­red and com­pre­hen­si­ble fashion.


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