OLG Celle on the obligations of distributors under Art. 14 MDR when distributing non-compliant medical devices in the context of unfair competition law

Co-Author: Cao, My Anh

A decision of the Higher Regional Court of Celle dated January 19, 2023 (Ref.: 13 U 79/21) deals with the classification of a product as an accessory to a medical device, the resulting indication of a four-digit identification number of a Notified Body in addition to a CE marking, and the implications for unfair competition law.

The defendant is a legally independent German factory representative of an Italian company that manufactures oil-free dry air compressors for the generation of compressed air. The plaintiff is a manufacturer of medical products for dental use and in particular also of compressors for the generation of compressed air for dental treatment. In the course of a test purchase, the plaintiff discovered that the product marketed by the defendant did not bear a four-digit identification number of a notified body, but a simple CE marking. The plaintiff sued for injunctive relief, arguing that the compressors were an accessory to a medical device because the instructions for use specified a medical purpose that was assigned to risk class IIa and thus required a conformity assessment procedure by a notified body. The indication of a four-digit identification number is to be indicated in addition to the CE marking under medical device law. Due to the lack of a sufficient declaration of conformity and the indication of the identification number, a violation of Section 3a UWG would result.

The Higher Regional Court of Celle ruled on January 19, 2023 (Ref.: 13 U 79/21) that the oil-free dry air compressor marketed by the defendant was to be classified as an accessory to a medical device within the meaning of Article 2 No. 2 MDR and required a four-digit identification number of a Notified Body in addition to the CE marking. The enclosed instructions for use of the defendant show that the compressors are to be used in the context of a medical treatment, which means that the manufacturer intended them to be used for medical purposes, which requires a conformity assessment procedure by a notified body. Since the compressors do not meet the requirements of the EU Medical Devices Regulation (MDR), the distributor is not allowed to distribute them on the market. According to Article 14 (1) MDR, the defendant as a distributor must exercise due diligence in making products available on the market. This requires basic knowledge of which devices require a declaration of conformity under medical device law, which already bear a corresponding CE marking, and requires the defendant to recognize medical devices and their accessories based on the instructions for use. However, the classification of the medical device into one of the risk classes, on the other hand, was not part of the formal examination of the defendant as a distributor. As a result, the Higher Regional Court of Celle affirmed a violation of competition law according to Section 3 HWG, because the regulation of Art. 14 MDR is a market conduct regulation in the sense of Section 3a UWG, which serves the safety, suitability and performance of medical devices and the health as well as protection of dentists and patients.