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.


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.


Stay up-to-date

We use your e-mail address exclusively for sending our newsletter. You have the right to revoke your consent at any time with effect for the future. For further information, please refer to our privacy policy.