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EU Parliament

EU Council Adopts New Measures to Prevent Medical Device Shortages

The European Union is taking proactive steps to prevent potential shortages of medical devices, particularly in-vitro diagnostic devices (IVDs), which are crucial for various medical diagnoses, including HIV, cancer, pregnancy, and COVID-19. On May 30, 2024, the EU Council adopted several measures aimed at addressing this issue by extending the transition period for certain high-risk …

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EU Parliament

Proposal to Postpone the EU IVDR

The European Commission has announced a proposal to delay the implementation of Regulation (EU) 2017/746 on In Vitro Diagnostic medical devices (IVDR). Although the IVDR has applied since 2022, data has shown that many manufacturers have not taken the plunge to transition to the new regulation. The previous EU Directive 98/79/EC covering IVDs was considered …

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EU Parliament

Translation and Language Requirements for Medical Device Companies

An official list of language requirements for each EU Member State has been published by the European Commission. This critical document also lists translations required for Graphic User Interface (GUI) used for software / apps, although this information is not available for each country. What’s more, these requirements have been published for both MDR and …

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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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MHRA Unveils AI-Airlock: Accelerating Healthcare Innovation with a Regulatory Sandbox

The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled plans to advance its innovative ‘regulatory sandbox,’ known as the AI-Airlock. This virtual space, monitored by regulators, offers developers a platform to establish robust evidence for their advanced technologies. The application of Artificial Intelligence (AI) in healthcare holds tremendous potential for enhancing patient outcomes, including …

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