Due diligence of the distributor - OLG Celle specifies obligations of the medical device distributor pursuant to Art. 14 para. 1 MDR
"When distributors make a product available on the market, they take due care to comply with the applicable requirements as part of their activities."
In its ruling of 19.01.2023 (13 U 79/21), the Higher Regional Court of Celle has now explained what is meant by the "due care" of a retailer.
The facts of the case
The German-based factory representative of an Italian manufacturer of oil-free dry air compressors for the production of dry air, a compressor from the Italian manufacturer. The dealership is a distributor within the meaning of the medical device regulations.
The compressor was certified in accordance with the Machinery Directive (2006/42 EEC) and provided with a corresponding CE mark. The compressor was not subjected to a conformity assessment procedure in accordance with the MDR or the former Medical Devices Act; the four-digit number of a Notified Body was missing from the CE marking.
According to the instructions for use and the information on the manufacturer's website, the compressor can be used by a dentist to operate rotating instruments for the purpose of removing particles from the patient's oral cavity or drying the teeth. A competitor objected to this and requested that the retailer be prohibited from marketing the compressor under this medical purpose, as the compressor lacked the corresponding certification as an accessory to a medical device, and also requested that a claim for damages be established. The competitor had previously acquired the product by way of a test purchase.
The decision of the OLG Celle
In the second instance, the Higher Regional Court of Celle ordered the retailer to refrain from marketing the compressor and also established the competitor's claim for damages.
First, the court briefly explained that the compressor - according to the manufacturer's instructions for use - is an accessory for medical devices that must undergo a conformity assessment by a notified body in accordance with the rules of the MDR.
The Higher Regional Court of Celle then affirmed the competitor's claim for injunctive relief: By placing the non-compliant product on the market, the retailer breached its duty of market conduct under Art. 14 (1) MDR and acted in an anti-competitive manner.
The court then defined the concept of due diligence:
"The concept of due care refers to the efforts that a person acting with ordinary prudence or reasonably undertakes to prevent harm to others, taking into account the circumstances."
OLG Celle, judgment of. 19.01.2023 - 13 U 79/21
Accordingly, the retailer must know
which products must be provided with the CE marking
which documents (e.g. EU Declaration of Conformity) must accompany the product
which language requirements exist for the labeling, instructions for use or other accompanying documents
which circumstances clearly indicate the non-compliance of the product.
The retailer must therefore formally check that the product bears the required conformity marking(s) (e.g. the CE marking) before making the product available.
The Higher Regional Court of Celle derives these due diligence obligations from the European Commission's "Blue Guide" on the implementation of product regulations in the EU 2016. This underlines the importance of the European Commission's interpretation aids for legal practice and as guidance for economic operators. The ruling goes on to say:
"Distributors must also have a basic knowledge of the legal requirements - including knowledge of which products are required to bear the CE marking and accompanying documentation - and should be able to identify which products are clearly non-compliant (Blue Guide, p. 148 under Annex VII). Formal verification of whether a product bears the required conformity marking requires basic knowledge of which product types require such a conformity marking together with a declaration of conformity and whether the product is one of them."
The distributor should therefore have known and recognized that the compressors it sells as accessories for medical devices may only be placed on the market with an MDR-compliant CE marking. As this would have been clear from the instructions for use for the compressors, the retailer breached its duty of care.
The Higher Regional Court of Celle went on to state that it is not part of the distributor's obligations under Art. 14 MDR to check whether the product has been classified in the correct risk class. Rather, the distributor's examination is limited to a formal examination of the information available to it and therefore not, for example, to the manufacturer's technical documentation, as it does not have access to this.
Effects on practice
With this ruling, the Higher Regional Court of Celle has tightened the requirements placed on distributors of medical devices. According to an earlier decision of the OLG Frankfurt, the dealer was only responsible under competition law in the "case of a clearly recognizable incorrect classification" (OLG Frankfurt, judgment of 21.01.1999 - 6 U 71/98). According to the OLG Celle, the following now applies: A retailer must know which products he is selling and whether these are medical products. In principle, he may not rely on the manufacturer's information being correct, but must check the medical device status of the products he sells himself. For example, if he sells an infrared lamp, he must know whether the manufacturer ascribes a medical purpose to it or whether the product is only intended as a lifestyle product. From this, he must then conclude whether it is sufficient if the product is only provided with a "simple" CE marking.
In practice, it is advisable to regulate this issue as part of the contractual agreements between the retailer and supplier. However, a delegation of the inspection obligations under Art. 14 MDR back to the supplier or manufacturer by way of a contractual agreement is not permitted - at least according to the legal interpretation set out in the MDCG 2012-27 - rather, each economic operator must fulfill the obligations incumbent on them under the MDR themselves. The distributor cannot therefore exempt itself from its obligations under competition law through a contractual agreement with the manufacturer.
Status: 17.05.2023