The “new” Medi­cal Device Regu­la­ti­on: a stress test for the medi­cal device industry

Due to the coro­na­vi­rus, the medi­cal device indus­try has been gran­ted an exten­ded tran­si­tio­nal peri­od with regard to the ent­ry into effect of the MDR. Howe­ver, some in the indus­try belie­ve that this exten­si­on is not real­ly long enough for com­pa­nies to con­form with the MDR in light of the chal­lenges asso­cia­ted with coronavirus.

One pro­blem facing manu­fac­tu­r­ers of Class 1s and 1m devices and devices in hig­her risk clas­ses rela­tes to the inter­pre­ta­ti­on of Artic­le 120 of the MDR, under which devices which were manu­fac­tu­red in con­for­mance with the Direc­ti­ves but for which valid cer­ti­fi­ca­tes were not issued by noti­fied bodies pri­or to the MDR’s effec­ti­ve date, 26 May 2021, may con­ti­nue to be pla­ced on the mar­ket and sold pro­vi­ded they under­go no signi­fi­cant chan­ges in the time sin­ce the MDR took effect. The ques­ti­on as to how the phra­se “signi­fi­cant chan­ges  in  the  design and  inten­ded pur­po­se” is to be unders­tood in any indi­vi­du­al case is alre­a­dy the sub­ject of inten­se dis­cus­sion among manu­fac­tu­r­ers and noti­fied bodies.

What is clear, and this is espe­ci­al­ly true for Class I devices, for which Artic­le 120 of the MDR does not app­ly – is that the requi­re­ments in the MDR should now be con­side­red bin­ding for medi­cal devices which are pla­ced on the mar­ket for the first time. Par­ti­cu­lar atten­ti­on should be paid to the fol­lo­wing aspects, whe­re the rules estab­lished by the MDR are stric­ter than before:

In addi­ti­on to com­ply­ing with the MDR, com­pa­nies will also have to keep in mind that natio­nal rules may also chan­ge as the MDR takes effect. In some cases, requi­re­ments for manu­fac­tu­r­ers, importers and dis­tri­bu­tors under natio­nal law will be even stric­ter than tho­se which were ori­gi­nal­ly set down in the MDR.

Con­clu­si­on and Recom­men­ded Action

Manu­fac­tu­r­ers who­se devices still have valid cer­ti­fi­ca­tes in accordance with the Direc­ti­ves should seek to obtain cla­ri­ty as to resi­du­al peri­ods and as to the limits and mea­ning of the sell-off pro­vi­si­on.  With respect to the pla­ce­ment on the mar­ket of new devices and Class I devices, the MDR’s requi­re­ments as well as the natio­nal rules should be hee­ded by manu­fac­tu­r­ers, importers and dis­tri­bu­tors alike.


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