MDR: new duties for importers of medi­cal devices

For the first time, the MDR (PDF) defi­nes gene­ral obli­ga­ti­ons for various eco­no­mic ope­ra­tors within the medi­cal devices indus­try, inclu­ding importers. As a result, importers are express­ly sub­ject to their own set of duties and face spe­ci­fic lia­bi­li­ty risks if tho­se duties are brea­ched. In some cases, manu­fac­tu­r­ers’ obli­ga­ti­ons may app­ly for importers as well.

Pur­su­ant to Artic­le 2 of the MDR, an “importer” is any natu­ral or legal per­son estab­lished within the Uni­on that places a device from a third coun­try on the Uni­on mar­ket. Depen­ding on whe­ther the Mutu­al Reco­gni­ti­on Agree­ment (MRA) curr­ent­ly being nego­tia­ted bet­ween the EU and Switz­er­land is signed or not, and whe­ther or not an agree­ment is rea­ched with the United King­dom upon expi­ra­ti­on of the “Brexit” tran­si­tio­nal peri­od, Switz­er­land and the United King­dom will also have to be trea­ted as “third count­ries” in terms of the MDR.

Gene­ral Obli­ga­ti­ons of Importers (Artic­le 13 of the MDR) 

The obli­ga­ti­ons for importers are spe­ci­fied in Artic­le 13 of the MDR. They rela­te both to pro­duct con­for­mi­ty in the nar­row sen­se and to inter­ac­tions bet­ween importers and other eco­no­mic ope­ra­tors, such as manu­fac­tu­r­ers, their aut­ho­ri­zed repre­sen­ta­ti­ves and the com­pe­tent super­vi­so­ry authorities.

Veri­fi­ca­ti­on and Coope­ra­ti­ve Duties

Importers may not place devices on the EU mar­ket unless tho­se devices com­ply with the MDR. Accor­din­gly, they are requi­red to veri­fy that the rele­vant devices have a CE mar­king and an EU decla­ra­ti­on of con­for­mi­ty. They are also requi­red to veri­fy that the devices are label­led cor­rect­ly, that their ins­truc­tions for use con­form to the MDR’s requi­re­ments and that they have a Uni­que Device Iden­ti­fi­ca­ti­on Num­ber (“UDI”). Importers also must be able to iden­ti­fy the device’s manu­fac­tu­rer and the latter’s aut­ho­ri­zed repre­sen­ta­ti­ve (EC Rep). 

If an importer has reason to belie­ve that a device fails to meet the MDR’s requi­re­ments, it may not place that device on the mar­ket until the device has been brought into con­for­mi­ty with the Regu­la­ti­on. In such a case, the importer is requi­red to noti­fy the manu­fac­tu­rer and its aut­ho­ri­zed representative.

Importers are also requi­red to coope­ra­te with the com­pe­tent aut­ho­ri­ties, at the latter’s request, in any action taken to eli­mi­na­te or, if that is not pos­si­ble, to miti­ga­te risks asso­cia­ted with devices which they have pla­ced on the mar­ket. This could extend as far as pro­vi­ding the com­pe­tent aut­ho­ri­ty with samples of the device free of char­ge or gran­ting the aut­ho­ri­ty access to the device. This aspect should be con­side­red when nego­tia­ting con­trac­tu­al agree­ments with the manu­fac­tu­rer. Depen­ding on the pri­ce of the device, the obli­ga­ti­on for importers to pro­vi­de the aut­ho­ri­ties with a “sam­ple” free of char­ge could be finan­ci­al­ly significant.

Labe­l­ing and Regis­tra­ti­on Obligations

Importers are requi­red to pro­vi­de infor­ma­ti­on on devices mar­ke­ted in the EU, on their pack­a­ging or on an accom­pany­ing docu­ment, about their name, their regis­tered trade name/trademark (if appli­ca­ble), their regis­tered place of busi­ness and the address at which they can be rea­ched. In doing so, they must ensu­re that any addi­tio­nal label does not obscu­re the infor­ma­ti­on on the label pla­ced by the manufacturer.

Importers are also requi­red to veri­fy that the device is regis­tered in the elec­tro­nic sys­tem pur­su­ant to Artic­le 29 of the MDR and they are to add their data pur­su­ant to Artic­le 31 of the MDR to this regis­tra­ti­on. Of cour­se, the­se obli­ga­ti­ons app­ly only if the EUDAMED data­ba­se is functioning.

Other Obli­ga­ti­ons

The abo­ve list is not exhaus­ti­ve. It does not include addi­tio­nal sta­tu­to­ry duties in con­nec­tion with the sto­rage and ship­ment of devices, the duty to keep a regis­ter of com­plaints and spe­cial docu­men­ta­ti­on requi­re­ments. 
Importers can­not do all this unless the manu­fac­tu­r­ers enable them to do so by sup­p­ly­ing importers with the neces­sa­ry docu­ments and infor­ma­ti­on. Importers should pay par­ti­cu­lar atten­ti­on to this point when for­mu­la­ting con­trac­tu­al agree­ments with manufacturers.

The Importer as Manu­fac­tu­rer (Artic­le 16 of the MDR)

The manufacturer’s obli­ga­ti­ons may fall to the importer in indi­vi­du­al cases. In accordance with Artic­le 16 of the MDR, this is the case if the importer does any of the following:

  • makes available on the mar­ket a device under its name, regis­tered trade name or regis­tered trade­mark, except in cases whe­re a dis­tri­bu­tor or importer enters into an agree­ment with a manu­fac­tu­rer wher­eby the manu­fac­tu­rer is iden­ti­fied as such on the label and is respon­si­ble for mee­ting the requi­re­ments pla­ced on manu­fac­tu­r­ers in this Regulation;
  • chan­ges the inten­ded pur­po­se of a device alre­a­dy pla­ced on the mar­ket or put into service;
  • modi­fies a device alre­a­dy pla­ced on the mar­ket or put into ser­vice in such a way that com­pli­ance with the appli­ca­ble requi­re­ments may be affected.

Chan­ges to the outer pack­a­ging of a device which has alre­a­dy been pla­ced on the mar­ket, inclu­ding chan­ges in pack size, do not make the importer into a manu­fac­tu­rer, pro­vi­ded the repack­a­ging is neces­sa­ry in order to mar­ket the device in the rele­vant mem­ber sta­te and pro­vi­ded that this is done under con­di­ti­ons which ensu­re that the ori­gi­nal con­di­ti­on of the device can­not be affec­ted. In case of devices which are pla­ced on the mar­ket in ste­ri­le con­di­ti­on, the ori­gi­nal con­di­ti­on of the pack­a­ging is con­side­red to be adver­se­ly affec­ted if the pack­a­ging that is neces­sa­ry for main­tai­ning the ste­ri­le con­di­ti­on is ope­ned, dama­ged or other­wi­se adver­se­ly affec­ted by the repack­a­ging. Importers which are plan­ning to repacka­ge devices must have a qua­li­ty manage­ment sys­tem of their own which ensu­res that the ori­gi­nal con­di­ti­on of the device is pre­ser­ved and that the pack­a­ging of the repacka­ged device is not defec­ti­ve, of poor qua­li­ty or untidy.


A wide varie­ty of new sta­tu­to­ry obli­ga­ti­ons will app­ly for importers once the MDR enters into effect. In cer­tain cases, they may even assu­me the role of manu­fac­tu­rer. Importers must be awa­re of this so that they can take the neces­sa­ry mea­su­res to duly com­ply with the­se obli­ga­ti­ons. If importers fail to do so, they may be expo­sed to far-reaching lia­bi­li­ty risks in the future due to their fail­ure to com­ply with the MDR.


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