Scope of veri­fi­ca­ti­on duties of medi­cal device distributors

Order for refe­rence for a preli­mi­na­ry ruling on the scope of veri­fi­ca­ti­on duties of medi­cal device distributors

On 21 Decem­ber 2023, the Ger­man Fede­ral Court of Jus­ti­ce (BGH) issued an order for refer­ral to the ECJ for a preli­mi­na­ry ruling pur­su­ant to Art. 267 (1) (b) TFEU. Five ques­ti­ons on the inter­pre­ta­ti­on of the Medi­cal Device Regu­la­ti­on (Regu­la­ti­on (EU) 2017/745, “MDR”) have been refer­red to the ECJ for answering.

Order for refer­ral and ques­ti­ons sub­mit­ted for a preli­mi­na­ry ruling

In terms of con­tent, the order for refer­ral by the BGH con­cerns the duties incum­bent on dis­tri­bu­tors of medi­cal devices in the light of Art. 14 MDR.

In a nuts­hell, the BGH requests ans­wers to the fol­lo­wing questions:

  • Is a dis­tri­bu­tor obli­ged under Art. 14 (1), (2) subs. 1 (a) MDR to veri­fy whe­ther the pro­duct it has made available on the mar­ket is to be regard­ed as a medi­cal device and the­r­e­fo­re has been CE mark­ed and whe­ther the manu­fac­tu­rer has drawn up an EU decla­ra­ti­on of con­for­mi­ty for a medi­cal device?
  • Does a dis­tri­bu­tor also have to veri­fy whe­ther the pro­duct falls under risk class IIa and must the­r­e­fo­re have been given a four-digit iden­ti­fi­ca­ti­on num­ber by a noti­fied body?
  • Is it rele­vant for the “reason to belie­ve” that a pro­duct made available on the mar­ket by the dis­tri­bu­tor is not in con­for­mi­ty with the requi­re­ments of the MDR that the dis­tri­bu­tor beco­mes awa­re of such a legal eva­lua­ti­on through a com­pe­ti­tor sen­ding the dis­tri­bu­tor a war­ning letter?
  • Does the ans­wer to the last ques­ti­on depend, inter alia, on the dis­tri­bu­tor being infor­med by the manu­fac­tu­rer or an aut­ho­ri­ty that the war­ning recei­ved is unfounded?

Ten­den­cy of the BGH

The ECJ has yet to ans­wer the ques­ti­ons refer­red to it.

As soon as the ECJ has ans­we­red the ques­ti­ons, the BGH will in any case have to deci­de again. Howe­ver, it is alre­a­dy clear which inter­pre­ta­ti­on results the BGH is hoping to recei­ve from the ECJ:

  • The wor­ding of Art. 14 MDR inde­ed does not requi­re that the dis­tri­bu­tor’s veri­fi­ca­ti­on duty within the mea­ning of the MDR is lin­ked to the clas­si­fi­ca­ti­on of the pro­duct as a medi­cal device by the manu­fac­tu­rer. Howe­ver, the dis­tri­bu­tor is only obli­ged to car­ry out veri­fi­ca­ti­on within the scope and limits of its acti­vi­ties and only with due care; the pro­per mar­king is pri­ma­ri­ly the respon­si­bi­li­ty of the manufacturer.
  • Howe­ver, the mea­ning and pur­po­se of Art. 14 MDR argue in favour of requi­ring the dis­tri­bu­tor to car­ry out a veri­fi­ca­ti­on, irre­spec­ti­ve of the fact that the pro­duct has been clas­si­fied as a medi­cal device by the manu­fac­tu­rer. This fol­lows from the pro­tec­ti­ve pur­po­ses of the MDR. Fur­ther­mo­re, the dis­tri­bu­tor has a key role accor­ding to the “Blue Guide”.

In this con­text, it is essen­ti­al for dis­tri­bu­tors that, in the opi­ni­on of the BGH, the veri­fi­ca­ti­on can also be car­ri­ed out by exami­ning the inten­ded pur­po­se of the docu­ments pro­vi­ded (ins­truc­tions for use, adver­ti­sing and sales materials).

  • The BGH fur­ther assu­mes that the­re is “reason to belie­ve” within the mea­ning of Art. 14 MDR at the latest when a dis­tri­bu­tor beco­mes awa­re of a pos­si­ble inf­rin­ge­ment through a war­ning let­ter from a com­pe­ti­tor. This is becau­se such “reason to belie­ve” can cover any aspect that a reasonable dis­tri­bu­tor – acting with ordi­na­ry pru­dence and making reasonable efforts in con­side­ra­ti­on of the cir­cum­s­tances of the indi­vi­du­al case to pre­vent harm to others – would con­sider as a reason to exami­ne the ques­ti­on of pro­duct mar­king. In this case, noti­fi­ca­ti­on to the manu­fac­tu­rer or an aut­ho­ri­ty is not suf­fi­ci­ent; making the pro­duct available on the mar­ket again is only per­mit­ted once con­for­mi­ty has been estab­lished. In this case, any obli­ga­ti­on to pay dama­ges to the manu­fac­tu­rer due to the fail­ure to dis­tri­bu­te the pro­duct is excluded.
  • The BGH does not under­stand Art. 14 MDR – neither with regard to its wor­ding nor with a view to the mea­ning and pur­po­se of the pro­vi­si­on – in such a way that it pro­vi­des for a duty to veri­fy whe­ther a noti­fied body must be and has been desi­gna­ted. In any case, the BGH con­siders the ques­ti­on to be open to inter­pre­ta­ti­on becau­se ans­we­ring this ques­ti­on requi­res com­plex legal and fac­tu­al considerations.


Art. 14 MDR for the first time pro­vi­des a com­pre­hen­si­ve legal frame­work gover­ning the scope of duties of medi­cal device dis­tri­bu­tors. A breach of the­se legal duties can give rise to lia­bi­li­ty claims by poten­ti­al­ly inju­red pro­duct users or pati­ents against the dis­tri­bu­tors them­sel­ves. It will be of essen­ti­al importance for dis­tri­bu­tors how the ECJ will posi­ti­on its­elf in par­ti­cu­lar on the ques­ti­on of the duty to veri­fy the risk class of the pro­ducts spe­ci­fied by the manu­fac­tu­rer. If the exis­tence of such a duty is affirm­ed, the scope of duties incum­bent on dis­tri­bu­tors will expand significantly.

If you are an importer and / or dis­tri­bu­tor of medi­cal devices and need sup­port in iden­ti­fy­ing your legal duties and their limits, plea­se do not hesi­ta­te to cont­act us. We will also be hap­py to assist you in draf­ting con­tracts with manu­fac­tu­r­ers, tra­ding plat­forms and customers.


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