Online dis­tri­bu­ti­on of medi­cal devices

Online dis­tri­bu­ti­on of medi­cal devices is express­ly addres­sed in Artic­le 6 of the MDR, which sta­tes that  a medi­cal device which is “offe­red by means of infor­ma­ti­on socie­ty ser­vices, as defi­ned in point (b) of Artic­le 1(1) of Direc­ti­ve (EU) 2015/1535, to a natu­ral or legal per­son estab­lished in the Uni­on” must com­ply with the requi­re­ments of the MDR. Artic­le 1(1)(b) defi­nes an infor­ma­ti­on socie­ty ser­vice as “any ser­vice nor­mal­ly pro­vi­ded for remu­ne­ra­ti­on, at a distance, by elec­tro­nic means and at the indi­vi­du­al request of a reci­pi­ent of services.” 

First, pro­vi­ders of the­se devices are sub­ject to the requi­re­ments for dis­tri­bu­tors in accordance with Artic­le 14 of the MDR.

Labe­l­ing requirements

The gene­ral duties for dis­tri­bu­tors of medi­cal devices are defi­ned in Artic­le 14 of the MDR.

Accor­din­gly, dis­tri­bu­tors are requi­red to veri­fy that:

  • the device has CE mar­king and that an EU Decla­ra­ti­on of Con­for­mi­ty has been drawn up;
  • the infor­ma­ti­on which is to be sup­pli­ed by the manu­fac­tu­rer has been included;
  • an UDI has alre­a­dy been assi­gned by the manu­fac­tu­rer, if applicable.

Sin­ce a copy of the EU Decla­ra­ti­on of Con­for­mi­ty for the offe­red device must be made available at the request of a com­pe­tent aut­ho­ri­ty in accordance with Artic­le 6(3) of the MDR, it would be advi­sa­ble to obtain a copy of this decla­ra­ti­on from each manu­fac­tu­rer befo­re inclu­ding devices in the online platform.

If a dis­tri­bu­tor is of the opi­ni­on or has reason to belie­ve that a device fails to meet the MDR’s requi­re­ments, it may not sup­p­ly the rele­vant device until its con­for­mi­ty has been estab­lished. In such a case, the dis­tri­bu­tor is requi­red to noti­fy the manu­fac­tu­rer or the manufacturer’s aut­ho­ri­zed repre­sen­ta­ti­ve. This noti­fi­ca­ti­on requi­re­ment also appli­es in case of poten­ti­al­ly non-conforming devices which have alre­a­dy been pla­ced on the mar­ket, and dis­tri­bu­tors are also requi­red to coope­ra­te with the com­pe­tent super­vi­so­ry aut­ho­ri­ties if necessary.

Pro­duct information

Dis­tri­bu­tors are also requi­red to veri­fy that the infor­ma­ti­on which is to be sup­pli­ed by the manu­fac­tu­rer in accordance with Artic­le 10(11) of the MDR has been included with the device. The refe­rence is to the infor­ma­ti­on requi­red in Annex I Chap­ter III Sec­tion 23 of the MDR, in the form of labe­l­ing and ins­truc­tions for use.

The labels for offe­red devices must con­tain the fol­lo­wing information:

  • the name or trade name of the device;
  • the inten­ded pur­po­se of the device;
  • the name and regis­tered trade name/registered trade­mark of the manufacturer;
  • the manufacturer’s address;
  • the name and address of the manufacturer’s aut­ho­ri­zed repre­sen­ta­ti­ve, if the manu­fac­tu­rer is not based in Europe;
  • infor­ma­ti­on about cer­tain pro­duct com­pon­ents and/or hazar­dous mate­ri­als (e.g. medi­cinal sub­s­tances, human or ani­mal blood/plasma tissues/cells, car­ci­no­ge­nic mate­ri­als, nano­ma­te­ri­als, etc.);
  • the device’s lot number/serial number;
  • the UDI car­ri­er, if applicable;
  • infor­ma­ti­on about the time limit for use of the device or the date of manufacture;
  • infor­ma­ti­on about any sto­rage or hand­ling conditions;
  • refe­rence to ste­ri­li­ty and ste­ri­liza­ti­on methods;
  • any war­nings or pre­cau­ti­ons to be taken; and
  • an indi­ca­ti­on if the device is inten­ded for sin­gle use.

Adver­ti­sing statements

In accordance with Artic­le 7 of the MDR, tho­se sup­p­ly­ing and adver­ti­sing medi­cal devices are pro­hi­bi­ted from using text, names, trade­marks, pic­tures and figu­ra­ti­ve or other signs which could mis­lead users or pati­ents with regard to the device’s inten­ded pur­po­se, safe­ty and performance.

In par­ti­cu­lar, they may not:

  • ascri­be func­tions and pro­per­ties to the device which it does not possess;
  • crea­te a fal­se impres­si­on regar­ding tre­at­ment or dia­gno­sis, func­tions or pro­per­ties which the device does not possess;
  • fail to inform the user of the expec­ted risks asso­cia­ted with use of the device in line with its inten­ded purpose;
  • recom­mend uses for the device other than tho­se which are iden­ti­fied as part of the inten­ded pur­po­se for which the con­for­mi­ty assess­ment was performed.

In addi­ti­on, a CE mar­king is a pre­re­qui­si­te for pla­ce­ment of medi­cal devices on the mar­ket. The CE mar­king indi­ca­tes that the device con­forms to the legal requi­re­ments appli­ca­ble to the device in accordance with Euro­pean rules. Accor­din­gly, a CE mar­king is a “must have” for dis­tri­bu­ti­on of the device, and is not just a par­ti­cu­lar kind of qua­li­ty seal. As a result, dis­tri­bu­tors may not adver­ti­se devices on their online plat­forms using terms like “CE-tested’ or “CE-certified”: the­se terms qua­li­fy as mis­lea­ding adver­ti­sing in terms of the Act Against Unfair Com­pe­ti­ti­on [Gesetz gegen den unlau­te­ren Wett­be­werb] (only in Ger­man). With regard to the term “CE-certified,” the fact is that a decla­ra­ti­on of con­for­mi­ty with an EU Direc­ti­ve (in the future, the MDR) is not the same as cer­ti­fi­ca­ti­on and award of a CE mar­king by an inde­pen­dent body.

Sum­ma­ry and recommendation

Even devices which are dis­tri­bu­ted via an online plat­form are requi­red to meet the MDR’s requi­re­ments. The CE mar­king must be affi­xed to the device or its pack­a­ging in a cle­ar­ly visi­ble, legi­ble and inde­li­ble man­ner. The device’s labe­l­ing must be complete.

Sup­pli­ers of medi­cal devices are sub­ject to the requi­re­ments for dis­tri­bu­tors in accordance with Artic­le 14 of the MDR.

Dis­tri­bu­tors should not modi­fy the manufacturer’s state­ments and pro­duct infor­ma­ti­on in any way. If they do so, the­re is a risk that the manufacturer’s duties and lia­bi­li­ty risks may be trans­fer­red to the online dis­tri­bu­tor. If the plat­form is acces­si­ble to con­su­mers, spe­cial requi­re­ments app­ly for adver­ti­sing state­ments. Vio­la­ti­ons of the­se requi­re­ments will be par­ti­cu­lar­ly inte­res­t­ing to com­pe­ti­tors, who will eager­ly use them as the basis for cea­se and desist let­ters and desis­tance actions.


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