The Case at Stake: For the first time since the Medical Device Regulation (EU) 2017/745 (“MDR”) became applicable, the Court of Justice of the European Union (“CJEU”) has had to spell out what Article 14 MDR asks of distributors. The reference came from the German Federal Court of Justice (Bundesgerichtshof – BGH) and grew out of a competitor dispute in the dental-equipment sector. A German company marketed oil-free dry-air compressors made by an Italian manufacturer; a rival German manufacturer of dental compressors objected to that distribution. The products carried a CE marking, but the underlying declaration of conformity rested on the Machinery Directive 2006/42/EC rather than the MDR, and they bore no four-digit notified-body number of the kind an MDR conformity assessment for a Class IIa device would demand – even though the German competent authority had previously treated comparable compressors as Class IIa devices. The claimant’s position was that, given their intended purpose, the compressors were accessories to a medical device and could lawfully reach the market only after an MDR conformity assessment with notified-body involvement, and that the distributor itself was bound to police that requirement. After test purchases and warning letters to the distributor came to nothing, the claimant sued for an injunction, and the BGH asked the CJEU how far a distributor’s verification duties under Article 14 MDR actually reach.
The Decision: In its judgment of 4 June 2026 (Case C-10/24, Dürr Dental), the Court began from the allocation of roles the MDR deliberately builds in. It is the manufacturer that knows its product, applies the CE marking and signs the declaration of conformity, so it is the manufacturer that bears the primary responsibility for the product’s conformity. A distributor, by contrast, owes only a duty of “due care” under Art. 14 para. 1 MDR. On the Court’s reading, that duty requires the distributor to satisfy itself that a CE marking and a declaration of conformity exist and, on the face of the information available, point to a product the MDR actually governs – but not to interrogate whether those documents are substantively right. Determining whether a product is a medical device is, as a rule, not the distributor’s task; its review is a formal one rather than a substantive re-examination.
Two qualifications take that duty past a pure paperwork exercise. The first flows from the obligation in Art. 14 para. 2 subpara. 3 MDR to act where there is reason to doubt a product’s conformity. The Court read this as requiring a kind of plausibility check: working from the documents in front of it or otherwise readily obtainable – the declaration of conformity, the labelling and instructions for use, the manufacturer’s website, any sales material – the distributor must register the cases where the CE marking and declaration plainly do not fit a product covered by the MDR. It need not work through highly technical files, and it must act only where the mismatch is obvious on the surface. The second qualification concerns risk class. A distributor is not expected to check – still less to correct – which class a device belongs to; the Court saw that as too intricate a judgment to place on distributors without eroding the clean division of responsibilities the Regulation is meant to keep. There is, however, one narrow exception: where the manufacturer’s own documents show that the device sits in a class that requires a notified body (IIa, IIb or III), the distributor’s due-care duty extends to confirming that the CE marking really does carry that notified body’s four-digit number.
The decision also addresses a very practical trigger – the competitor’s warning letter. Such a letter can be enough to give a distributor reason to suspect non-compliance. But if the distributor then puts the point to the manufacturer and the manufacturer maintains that all is in order, the distributor may take that answer at face value and does not breach Art. 14 MDR – unless the manufacturer’s position is plainly untenable. And where the distributor goes further and refers the matter to the competent national authority, a clear and reasoned decision from that authority rejecting the complaint lays any remaining doubt to rest.
This is important for distributors and other operators (such as importers) in the medical device (and IVD) supply chain:
The worth of the ruling is that it draws a workable line. Distributors need not reproduce the manufacturer’s conformity assessment or run a classification of their own; equally, they cannot shelter behind a complete-looking set of documents when a product’s stated purpose and the regulatory route under which it is marked visibly fail to align. It is precisely that gap – between what the product is for and the regime under which it is CE-marked – that a distributor now has to watch for.
- Treat the plausibility check as a standing process, not a one-off. The point is not whether a product bears a CE marking but which regime that marking invokes: staff should compare the product’s stated purpose with the framework its CE marking and declaration of conformity actually rest on – labelling, instructions for use, the manufacturer’s own website, sales material – and pay particular attention to products that sit at the dividing line between ordinary machinery or software and a medical device. Build the check into product-intake routines.
- Make the notified body number a fixed checkpoint. Where the manufacturer’s own documents point to Class IIa, IIb or III, confirm that the CE marking carries that body’s four-digit number before the product is supplied.
- Set up a clear escalation path for warning letters. Record the query put to the manufacturer, assess whether its answer is at least defensible rather than plainly untenable, and, if doubt remains, involve the competent authority and await its reasoned position before continuing to supply.
- Document all of this. The Court’s standard is light, but it is real, and a recorded plausibility check is what demonstrates that the duty of care was met.
- Tighten distribution agreements accordingly. The ruling turns the manufacturer/distributor interface into a documented one, so contracts should set out which CE documentation the manufacturer must supply, have it warrant the regulatory framework under which the product is placed on the market, and allocate responsibility – and indemnities – for an incorrect classification, rather than leaving the split to be reconstructed once a dispute has arisen.
- Read the ruling across to importers. Although it interprets Article 14 MDR, importers carry their own, closely parallel verification duties under Article 13 MDR; the Court’s distinction between a formal check and a substantive re-classification – and its handling of warning letters – should shape how those duties are applied in practice.
- Apply the same logic under the IVDR. The economic-operator provisions of the In Vitro Diagnostic Regulation (EU) 2017/746 mirror the MDR almost word for word, so the standard set here for MDR distributors should carry over directly to distributors – and importers – of in vitro diagnostic medical devices.
- Look beyond medical devices altogether. The MDR’s operator obligations follow the horizontal New Legislative Framework (Decision No 768/2008/EC) that also underpins CE marking for machinery, electrical equipment, personal protective equipment and toys, among others; the Court’s calibration of how far a distributor must look – a formal check coupled with a duty to act on manifest inconsistencies – is therefore likely to influence distributor duties in those sectors too, well beyond medtech.
