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 Coöpe­ra­ti­ve 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 coöpe­ra­te 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.

Con­clu­si­on

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.

back

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.