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援用“用藥五對”和患者平安统计的促销質料被认定為纯促销语境，不组成预期用處的决议性数据。企業在营销材猜中應區别“產物功效描写”與“行業布景信息”，防止因促销话術激發定性争议。
CE標记不克不及“反向定性”產物：
仅因营销目標贴CE標记不克不及扭转產物的客觀定性。反過来，從已组成醫療器械的產物中删除醫療說话也不會使其離開MDR。瘦身產品,定性取决于產物的客觀功效和制造商的真實预期用處。
经销商核對义務以“先定性”為条件：
MDR第14条义務仅在產物组成醫療器械時触發。经销商在醫療器械和非醫療產物夹杂谋划時，须先果断產物是不是落入MDR范畴，再决议是不是履行核對义務。未完成定性的產物经销放置存在合规危害。
Snitem行政/临床功效區别框架合用于實體產物定性：
法院将Snitem案中“行政功效與临床功效”阐發框架從软件扩大到實體產物，确立了更遍及的合用性。這對海内企業開辟的多功效醫療平台產物（含行政模块和临床模块）具备直接引导意义。
反不合法竞争法可成為MDR定性的間接路径：
本案经由過程德國反不合法竞争诉讼而非羁系法律达到欧盟法院，表白產物定性問題可经由過程海内民事诉讼被“强迫公然”。企業在欧盟市場的竞争敌手可能操纵反不合法竞争法挑战產物定性，而非仅依靠羁系機構法律。
???? 原文链接
• Osborne Clarke律所阐發（2026年7月31日）：
• CJEU裁决书（Case C-427/24）：
• Snitem案（C-329/16）：
• Team-NB最好實践指南：
• MDR律例全文（Regulation (EU) 2017/745）：
ENGLISH ORIGINAL
Core Ruling
Court of Justice of the European Union (CJEU) has held in Zentrale zur Bekämpfung unlauteren Wettbewerbs v Diagra妹妹 Halbach that blank thermoplastic patient identification wristbands, which can be printed with patient data but supplied unprinted, cannot be classified as medical devices under the EU Medical Devices Regulation (MDR). The ruling, handed down on 2 July in case C-427/24, arose from a dispute over a German unfair competition claim against a distributor that had sold the wristbands without verifying CE marking or an EU declaration of conformity.
Intended Purpose and Manufacturer Data
Article 2 (12) of the MDR defines intended purpose as the use for which a device is intended according to data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements, or as specified in the clinical evaluation. Two formal conditions follow: first, the data on intended use must come from the manufacturer; second, they must appear in one of the carriers listed in article 2 (12). Zebra's promotional document satisfied both conditions and therefore contributed, in principle, to determining intended purpose. However, the CJEU further suggests that not every manufacturer statement carries equal weight. The wording of article 2 (12) places the emphasis on the use for which the product is intended, so only data that actually relate to that use are decisive. Contextual information that is merely useful and designed to promote sales is not decisive for determining intended purpose.
Objective Medical Function
Applied to the wristbands, the court found that they were objectively incapable, by themselves, of providing a "medical service" – the English rendering of medizinische Leistung/prestazione medica in paragraph 28 of the judgement – even though used in a medical context. Supplied unprinted, the bands were not intended to fulfil a specific medical purpose or to exert a physical effect on the human body and they performed none of the therapeutic, diagnostic or other medical purposes listed in article 2 (1). Correct identification of the patient was their sole objective; all of the medical purposes listed i血糖克星,n Article 2 (1) depended on other factors, independent of whether the patient wore such a wristband. The same identification result could be achieved by a nameplate, badge or identity document, which fulfil purely administrative functions.
Snitem Analogy Rejected
The Wettbewerbszentrale sought to transpose the reasoning of the court in Snitem and Philips France (C-329/16) from softwa大老爺娛樂城儲值,re to the wristbands, arguing that a comparable analysis should bring the products within Article 2 (1) of the MDR. The CJEU rejected that analogy. Restating Snitem, the court recalled that software falls within the medical device definition where it does more than perform purely administrative tasks: in that earlier case, the software processed patient-specifi血糖克星,c data and, on that basis, generated information capable of assisting a doctor in the doctor's clinical work. The analogy did not hold on the facts before the referring court. The治療過敏性鼻炎, wristbands, supplied unprinted, did not process or otherwise include patient data and generated no information of any kind for a clinician. |
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