The CJEU has delivered a preliminary ruling in Case C-427/24 Diagramm Halbach, which provides guidance on determining whether a product is a medical device within the meaning of Regulation (EU) 2017/745 (“MDR”). The judgment confirms that the manufacturer’s advertising of a product is not necessarily decisive in determining whether it has a “medical purpose” within the definition of “medical device” under the MDR, and that the product must also objectively perform one (or more) of those medical purposes to fall within that definition. The judgment also provides guidance on what constitutes a solely administrative function that does not fall within those medical purposes. The decision has the potential to guide other classification decisions of borderline products used in the healthcare sector.
Continue Reading CJEU ruling clarifies scope of medical device definitionMedical Device Coordination Group
EU announces pilot coordinated assessment for clinical investigations of medical devices
By Arnold & Porter, Christopher Bates & Mimi Simmons on
On 6 February 2025, EU Member States announced the launch of a new pilot scheme for coordinated assessment of clinical investigations of medical devices (CI) and performance studies for in vitro diagnostic (IVD) medical devices (PS). Supported by the European Commission, the pilot allows sponsors to submit a single CI or PS application for review across multiple Member States, rather than each Member State conducting independent standalone reviews. The pilot scheme aims to make the application process for multi-national CI and PS more efficient and to reduce the duplication of activities by both the sponsor and competent authorities. As this has been a major cause of delays and complications in conducting CIs, this pilot will be welcomed by industry.
Continue Reading EU announces pilot coordinated assessment for clinical investigations of medical devices