The Medical Device Coordination Group (MDCG) published a number of guidance documents lately.
MDCG 2024-10, Clinical evaluation of orphan medical devices, provides advice for generating clinical data for devices that are intended for use in rare diseases/conditions or specific indications for rare cohorts of patients with non-rare diseases/conditions. More specifically, it addresses questions like, “How does a manufacturer justify orphan device status?” or “What type of facilities are granted for orphan devices?”
MDCG 2021-5, rev. 1, Guidance on standardisation for medical devices, is an update to the document that was initially published in 2021. It provides amendments and supplements to the initial release. For example, MDCG 2021-5, rev. 1, contains relevant court rulings in the context of standardization and updates on the concept of “state of the art”.
MDCG 2020-16, rev. 3, Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, is a new update to the document that was initially published in 2020. It provides guidance on the classification of IVD medical devices. Revision 3 contains a number of editorial changes and revised examples. In addition, MDCG 2020-16, rev. 3, also adds the definition of a kit.
The MDCG also published 2024-1-5, Guidance on the vigilance system for CE-marked devices, DSVG 05, Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence. It provides specific advice for handling the aforementioned devices within a manufacturer’s vigilance system.
The documents can be accessed in our download section.
Source: European Commission
