Com­pli­an­ce with the MDR? The wave of warnings is coming!

Manu­fac­tu­rers of medi­cal devices are requi­red to heed the requi­re­ments of the MDR as of 26 May 2021, and manu­fac­tu­rers of in-vitro dia­gnostics are requi­red to com­ply with the pro­vi­si­ons of the IVDR as of 26 May 2022.

Devices in hig­her risk clas­ses may still be cove­r­ed by tran­si­tio­nal peri­ods in some cases, in which case they may still be pla­ced on the mar­ket and sup­plied in accordance with the Direc­ti­ves pre­vious­ly in effect until the tran­si­tio­nal peri­ods expire.

The grace peri­od is over

For devices in lower risk clas­ses, spe­ci­fi­cal­ly Class I medi­cal devices and Class A IVDs, the­se tran­si­tio­nal rules no lon­ger apply.

In other words, the­se devices must (alrea­dy) com­ply with the MDR and/or IVDR effec­ti­ve immediately!

But this is fre­quent­ly not the case in prac­ti­ce. Mar­ket regu­la­tors and com­pe­ti­tors have yet to respond in a sys­te­ma­tic man­ner, likely due to the coro­na­vi­rus pan­de­mic as well as to their own need to obtain an over­view of the “new” regu­la­ti­ons and, in case of manu­fac­tu­rers, due to the need to ensu­re that their own pro­ducts and pro­duc­tion con­form to the new regu­la­ti­ons. Howe­ver, the­se cir­cum­s­tan­ces are now changing.

A wave of warnings is coming

The fact is that more and more com­pa­nies, inclu­ding non-European manu­fac­tu­rers, are not only fami­li­ar with the requi­re­ments of the MDR and the IVDR but are now in a posi­ti­on to manu­fac­tu­re and place their devices on the mar­ket in accordance with the new legal requi­re­ments. They have spent time and money to achie­ve this goal and right­ly belie­ve that they are at a dis­ad­van­ta­ge rela­ti­ve to com­pe­ti­tors which have not made the­se efforts. The­se manu­fac­tu­rers are beco­m­ing more proac­ti­ve and are no lon­ger con­tent with the abi­li­ty to mar­ket their own devices as CE-marked medi­cal devices. Ins­tead, they are tar­ge­ting com­pe­ti­tors and com­pe­ting pro­ducts by issuing warnings, filing for tem­pora­ry injunc­tions and making refer­rals to mar­ket regulators.

Sur­veil­lan­ce aut­ho­ri­ties may pro­hi­bit distribution

At the same time, most com­pe­tent sur­veil­lan­ce aut­ho­ri­ties have adap­ted to the rea­li­ty of the MDR and are no lon­ger pri­ma­ri­ly con­cer­ned with con­for­mi­ty assess­ments for sur­gi­cal masks and per­so­nal pro­tec­ti­ve equip­ment. They too are incre­a­singly “aiming” at veri­fy­ing the com­pli­an­ce of Class I devices with the MDR: the focus is now on patches, tapes, hea­ting pads, ban­da­ges, etc. as well as fascia rolls, ergo­no­mic seat cushions and com­pres­si­on appa­rel. The list is endless.

The finan­cial con­se­quen­ces for manu­fac­tu­rers of the­se devices, as well as dis­tri­bu­tors, are seve­re and may even be cata­stro­phic in some cases: dis­tri­bu­ti­on of non-conforming devices may be pro­hi­bi­ted by the aut­ho­ri­ties until com­pli­an­ce with the MDR is achie­ved and documented.

Con­clu­si­on

If they have not done so alrea­dy, manu­fac­tu­rers of Class I medi­cal devices and Class A IVDs should immedia­te­ly con­cern them­sel­ves with the regu­la­to­ry requi­re­ments for their devices and ensu­re their con­for­mi­ty befo­re com­pe­ti­tors and/or mar­ket regu­la­tors com­pel them to do so. Once com­pe­ti­tors and the aut­ho­ri­ties are aler­ted to a lack of con­for­mi­ty, the­re will often be only enough time to miti­ga­te the dama­ges, but a self-determined cour­se of action is no lon­ger possible.

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