Setting the scene for EU reference labs for high-risk diagnostics

On June 17, 2022, the European Commission introduced two implementing acts establishing the foundation for EU reference laboratories dedicated to high-risk in vitro diagnostic testing. These measures aim to support consistent evaluation and oversight across member states.

Guide to Performance Studies Conducted in Ireland

The Health Products Regulatory Authority (HPRA) has released a guide outlining the legislation and central principles related to performance studies involving in vitro diagnostic medical devices (IVDs). The document also clarifies the procedures for submitting applications and notifications to the HPRA.

UK to strengthen regulation of medical devices to protect patients

The UK government has published proposals intended to enhance patient safety while fostering medical innovation through updated regulatory approaches to medical devices.

Consultation on future medical device regulation

The MHRA completed a consultation focused on broadening the UK’s regulatory scope to align with internationally accepted definitions recognized by the Global Harmonization Task Force and the International Medical Device Regulators Forum (IMDRF). The initiative considers advancements in medical technology, engineering, and clinical science to modernize regulatory requirements for medical devices and IVDs.

NICE releases real-world evidence guidance

The National Institute for Health and Care Excellence (NICE) has issued new guidance to strengthen the quality and application of real-world evidence. The goal is to improve insights into health and social care systems while advancing patient treatment and outcomes.

General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma

The U.S. Food and Drug Administration has proposed reclassifying optical diagnostic tools for melanoma assessment and electrical impedance spectrometers—currently categorized as class III devices—into class II (special controls). These devices, intended to provide supporting diagnostic information for lesions suspected of melanoma, would become subject to premarket notification requirements under the new classification.