Q&A cata­log for importers and dis­tri­bu­tors of medi­cal devices

Importers and dis­tri­bu­tors may have the obli­ga­ti­ons of manu­fac­tu­r­ers in accordance with Artic­le 16 MDR in cer­tain cases. This is the case, for ins­tance, when a dis­tri­bu­tor or importer makes a medi­cal device available on the mar­ket under its own name, chan­ges the inten­ded pur­po­se of the medi­cal device, or makes other chan­ges to the device that could affect its com­pli­ance with appli­ca­ble legal requi­re­ments. For details, see our pre­vious news.

Artic­le 16(2) MDR spe­ci­fies the cases in which cer­tain acti­vi­ties of importers and dis­tri­bu­tors are not con­side­red to be chan­ges to a device within the mea­ning of Artic­le 16(1)© that could affect the com­pli­ance of the device with the appli­ca­ble requi­re­ments. In such cases, importers and dis­tri­bu­tors do not assu­me the manufacturer’s obli­ga­ti­ons.

The­se cases involve:

  • (a) pro­vi­si­on of infor­ma­ti­on, trans­la­ti­on of the infor­ma­ti­on pro­vi­ded by the manu­fac­tu­rer, inclu­ding the ins­truc­tions for use (IFU), neces­sa­ry for pla­cing the device on the mar­ket in the Mem­ber Sta­te (rela­be­l­ing).
  • (b) chan­ges to the outer pack­a­ging of a device alre­a­dy pla­ced on the mar­ket which are neces­sa­ry for pla­cing the device on the mar­ket in the Mem­ber Sta­te con­cer­ned (repack­a­ging).

The importers and dis­tri­bu­tors refer­red to in Artic­le 16(2) are sub­ject to obli­ga­ti­ons dif­fe­rent from than tho­se of the manu­fac­tu­rer descri­bed in Artic­le 16(3) and (4) MDR.

Gui­dance docu­ment MDCG 2021–26

The MDCG 2021–26 Gui­dance Docu­ment (PDF) addres­ses rele­vant aspects for the eco­no­mic ope­ra­tors car­ry­ing out any of the acti­vi­ties refer­red to in Artic­le 16(2)(a) and (b) of the Regu­la­ti­ons, i.e. rela­be­l­ing and/or repack­a­ging of devices.

It pro­vi­des assis­tance and ans­wers to the fol­lo­wing questions:

  • Do Artic­les 16(2), (3) and (43) app­ly only to importers and dis­tri­bu­tors or also to “other natu­ral or legal per­sons” as men­tio­ned in Artic­le 16(1)?
  • Do Artic­le 16(3) and (4) MDR app­ly to “lega­cy devices”?
  • For the acti­vi­ties refer­red to in Artic­le 16(2)(a) and (b), what is meant by ’neces­sa­ry to mar­ket the device’ in the Mem­ber Sta­te question?
  • Does the divi­si­on of lar­ge quan­ti­ties of devices in ship­ping con­tai­ners into smal­ler quan­ti­ties of devices in packa­ges or indi­vi­du­al units fall under Artic­le 16(2)?
  • What infor­ma­ti­on should be pro­vi­ded to the manu­fac­tu­rer pur­su­ant to Artic­le 16(4)?
  • What infor­ma­ti­on is must be repor­ted to the com­pe­tent aut­ho­ri­ty pur­su­ant to Artic­le 16(4)?
  • Must the manu­fac­tu­rer and the com­pe­tent aut­ho­ri­ty be noti­fied each time an indi­vi­du­al device or batch of devices is rela­be­led or repackaged?
  • Under what con­di­ti­ons should a noti­fi­ca­ti­on sent to the manu­fac­tu­rer and the com­pe­tent aut­ho­ri­ty be car­ri­ed out?
  • Must the manu­fac­tu­rer and the com­pe­tent aut­ho­ri­ty be noti­fied when an importer or dis­tri­bu­tor stops rela­be­l­ing and/or repackaging?
  • What noti­fied bodies can importers and dis­tri­bu­tors turn to for the
  • cer­ti­fi­ca­ti­on pur­su­ant to Artic­le 16(4)?
  • Is rela­be­l­ing and/or repack­a­ging of Class I and Class A in vitro dia­gno­stic medi­cal devices also sub­ject to review by a noti­fied body as defi­ned in Artic­le 16(4)?
  • Can the importer or dis­tri­bu­tor pro­vi­de addi­tio­nal batch num­ber infor­ma­ti­on while rela­be­l­ing and/or repackaging?
  • If the ins­truc­tions for use are trans­la­ted, is it neces­sa­ry to keep the ori­gi­nal ver­si­on of the ins­truc­tions for use in the packaging?
  • Do jobs that requi­re rela­be­l­ing and/or repack­a­ging acti­vi­ties pur­su­ant to
  • Artic­le 16(2) of the Regu­la­ti­on, com­ply with any obli­ga­ti­ons regar­ding tracea­bi­li­ty and uni­que device iden­ti­fi­ca­ti­on (UDI11)?

Prac­ti­cal use of the Gui­dance Docu­ment and recom­men­ded action

From this, it can be seen that the MDCG alre­a­dy addres­ses in gre­at detail poten­ti­al com­pre­hen­si­on pro­blems and any issues in light of Artic­le 16 MDR. For importers and dis­tri­bu­tors, the MDCG’s recom­men­da­ti­ons should the­r­e­fo­re be a valuable aid in posi­tio­ning them­sel­ves to be MDR-compliant.

Nevert­hel­ess, it remains essen­ti­al to careful­ly check the spe­ci­fic rela­be­l­ing or repack­a­ging for MDR com­pli­ance on a case-by-case basis. Ulti­m­ate­ly, this is the only way to pre­vent the respec­ti­ve pro­cess from (unin­ten­tio­nal­ly) resul­ting in manu­fac­tu­rer obli­ga­ti­ons and the asso­cia­ted lia­bi­li­ty risks for the importer or distributor.


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