Month: December 2023

EU Parliament

MDCG 2023-5: Guidance on qualification and classification of Annex XVI products

Introduction MDCG 2023-5 provides crucial insights into the Regulation (EU) 2017/745 on medical devices (MDR) as it pertains to products without an intended medical purpose, specifically those listed in Annex XVI. Understanding the intricate relationship between the MDR and common specifications (CS) is essential for manufacturers and notified bodies. The guidance serves as a comprehensive …

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EU Parliament

MDCG 2023-6: Equivalence Guidance for Annex XVI Devices

Introduction The MDR (Regulation (EU) 2017/745 on medical devices) provides a pathway to incorporate clinical data from an equivalent device in the assessment of a device’s conformity. While conducting a clinical investigation is the conventional means of acquiring data for CE marking, the MDR allows the utilization of data from a device with demonstrated equivalence. …

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EU Parliament

EU Reference Laboratories Designated

On December 5, 2023, the European Commission implemented an act designating 5 EU Reference Laboratories (EURLs) for in vitro diagnostic medical devices (IVDs). These EURLs will handle the conformity assessment of high-risk (class D) IVDs and perform advisory tasks. They cover categories such as Hepatitis and retroviruses, Herpesviruses, Bacterial agents, and Respiratory viruses causing life-threatening …

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