A. Facts of the case
The judgment arose from a competition law dispute between Dürr Dental and Cattani Deutschland concerning dry air compressors distributed by the latter in Germany. During two test purchases (in November 2020 and early 2021), Dürr Dental found that, whilst the compressors distributed by Cattani Deutschland bore a CE marking, this referred exclusively to the EC Machinery Directive (Directive 2006/42/EC) and not to the MDR applicable to medical devices; furthermore, the four-digit identification number of a Notified Body was missing. At its core, the case concerned the testing obligations regarding the CE marking of products in accordance with Article 14(2) subpara. 1 lit. a MDR, as well as the prohibition on making products available in accordance with Article 14(2) subpara. 3 MDR, in the event that the distributor has reason to believe that the products are non-compliant.
The legal dispute reached the Federal Court of Justice (BGH), which referred several questions of interpretation to the ECJ for a preliminary ruling.
B. Key grounds for the ECJ’s ruling
The ECJ had to rule on a total of five preliminary questions. This article focuses on the first and second questions referred.
I. First and second questions referred
The first and second questions referred for a preliminary ruling concerned the scope of a distributor’s duty to verify the CE marking – in particular, whether a distributor must verify whether the product supplied falls within the scope of the MDR at all, and whether it is relevant in this respect that the manufacturer has affixed a CE marking designating the product as a ‘machine’ within the meaning of Directive 2006/42. It was undisputed that the compressors were to be regarded as accessories to a medical device within the meaning of the MDR and had therefore in fact been incorrectly qualified.
The ECJ reached the following conclusion in this regard: Article 14(1) and (2) subpara. 1 lit. a MDR must be interpreted as meaning that, as part of their duty of care, distributors must assess, on the basis of the information available to them, whether the CE marking and the EU declaration of conformity for the product they place on the market obviously relate to a product falling within the scope of the MDR.
Under Article 14(1) MDR, when placing a product on the market, distributors must, in the course of their activities, ‘act with due care in relation to the requirements applicable’. Article 14(2 subpara. 1 MDR stipulates that, before placing a product on the market, distributors must, amongst other things, verify that
- the product bears the CE marking and,
- an EU declaration of conformity has been issued for the product,
- the product is accompanied by the required information,
- the importer complies with the requirements specified for the product and,
- where applicable, a Unique Device Identification (UDI) system has been assigned by the manufacturer.
According to the ECJ, the wording of the provision merely indicates that the distributor must verify whether a CE marking and an EU declaration of conformity exist for the product in question, but not whether their content is correct. Both the affixing of the CE marking and the issuance of the EU declaration of conformity fall within the sole responsibility of the manufacturer of the product (Article 10(6) MDR in conjunction with Articles 19 ff. MDR). Consequently, the obligation to verify a product’s conformity with the applicable regulations generally falls within the responsibility of the manufacturer and not the distributor.
Nevertheless, pursuant to Article 14(2), subpara. 3, sent.1, half-sent. 1 MDR, a distributor must not make a product available if they believe, or have reason to believe,
II. Third question referred for a preliminary ruling
With regard to the third question, the ECJ concluded that Article 14(2), subpara.1lit. a MDR, read in conjunction with Article 14(1) MDR, ‘must be interpreted as meaning that a distributor is not obliged to verify whether the device it places on the market falls within risk class IIa within the meaning of that Regulation and must therefore be marked with a four-digit identification number issued by a Notified Body. However, if the information available to the distributor indicates that the manufacturer has classified this product into a risk class requiring the involvement of a Notified Body, the distributor’s duty of care includes verifying whether the four-digit identification number of that body is present.’
III. Fourth and fifth questions referred
With regard to the fourth and fifth preliminary questions, the ECJ concluded that Article 14(2) subpara. 3 MDR ‘must be interpreted as meaning that a distributor may have grounds to believe that a product does not comply with Regulation 2017/745 if a competitor issues a warning to the distributor regarding the non-compliance of that product. If the manufacturer, when consulted by the distributor, considers that the alleged non-conformity does not exist, the distributor cannot be held to have breached its obligations under that provision by endorsing the manufacturer’s opinion, unless that opinion appears to the distributor to be manifestly incorrect. Where the distributor has informed the competent national authority in accordance with this provision, any doubts expressed thereby as to the conformity of the product in question shall be unreservedly dispelled by a reasoned and unequivocal statement from that authority refuting the alleged non-conformity.’
C. Classification under product law
I. MDR
The ECJ has confirmed that there is an obligation to verify compliance under the MDR. However, this is not a new finding, as this is precisely what is laid down in Article 14(2) subpara. 2 lit. a MDR. What is decisive, rather, is the scope of this obligation to verify: Is this a purely formal obligation to verify that a CE marking is present and an EU declaration of conformity has been issued, or must the distributor, as part of their duty of care, also assess the accuracy of the content?
The conclusion is clear with regard to the MDR: the verification obligations must be fulfilled as part of a ‘consistency check’. Since the MDR – unlike other harmonisation acts – does not require the EU Declaration of Conformity to be attached to the product, the distributor must actively request it in order to be able to fulfil their primary duty of verification at all. Consequently, the distributor must in any case examine all documentation and, logically, take action in the event of obvious discrepancies, as the duty of verification would otherwise be rendered meaningless. This is in line with Article 14(2) subpara. 3 sent. 1 MDR: according to this provision, a distributor may not make a product available on the market if they have reason to believe, or consider, that it is non-compliant; furthermore, they must inform the manufacturer accordingly.
II. Scope beyond the MDR
Although the ECJ has provided clarity with regard to the MDR, it is not possible to infer from the judgement a generalised duty to check or even investigate in relation to other harmonisation acts. A duty to check can only exist where it is laid down by law – as is the case in the MDR. In fact, however, obligations on distributors comparable to those in Article 14 MDR exist in almost all other (non-food) product sectors. It should also be noted that the distributor has a formal duty to verify solely on the basis of the documents and information readily available to them. This is the essence of the ‘coherence check’, which is ultimately a plausibility check. If an EC or EU declaration of conformity is not supplied with the product – as is the case, for example, under the EC Toys Directive (Directive 2009/48/EC) or the new EU Packaging Regulation (PPWR) – the trader cannot be expected from the outset to request and verify it without good reason. This applies all the more so where the trader – as under the PPWR – is not required to check the necessary documentation in the first place. Any duty to investigate, if it exists at all, would only arise where there are indications of potential discrepancies, for example in the form of a warning letter from a competitor. Consequently, the position remains that, whilst retailers must check whether a product is correctly classified in other product sectors or – with regard to the EU General Product Safety Regulation (GPSR) – in the area of non-harmonised consumer products, this check does not go beyond a simple verification of the evidence provided. In the absence of, for example, a warning letter from a competitor or an obviously incorrect product classification, the retailer may, in principle, assume that the manufacturer’s product classification is correct, particularly as the manufacturer has the best knowledge of its own product.
D. Outlook
With regard to the first and second questions of interpretation, the ECJ has held that the question of the extent to which the distributor is required, under the MDR, to verify whether the CE marking to be affixed by the manufacturer is manifestly incorrect must be answered on a case-by-case basis, taking into account the available documentation and information, including that which is readily accessible. Irrespective of this, responsibility for the conformity of products with the MDR remains with the manufacturer. The BGH must now decide whether the distributor’s efforts in the underlying case were sufficient. The benchmark here is an assessment taking into account all the circumstances of the individual case. The BGH’s decision is still pending.
For further reading: Handorn, MPR 2024, 100
Do you have any questions about this news item, or would you like to discuss it with the author? Please feel free to contact: Prof. Dr. Boris Handorn, Anna Christ and Dr. Carsten Schucht
