July 6, 2022
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Medical Devices – USA/Europe Regulatory Updates Roundup, June 2022

EUROPE (EU)

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


On 17 June 2022, the European Commission adopted two implementing acts to lay the groundwork for EU reference laboratories for high-risk diagnostics.

IRELAND (HPRA)

Guide to Performance Studies Conducted in Ireland

The purpose of this guide is to provide an overview of legislation and key concepts relevant to performance studies (PS) involving in vitro diagnostic medical devices (IVDs). In addition, information is provided on how to submit applications or notifications to the Health Products Regulatory Authority (HPRA).

UK (MHRA)

UK to strengthen regulation of medical devices to protect patients

New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published.

Consultation on the future regulation of medical devices in the United Kingdom

The MHRA consulted on amending the scope of the UK medical device regulations. Proposals would bring into scope medical devices and in vitro diagnostic medical devices (IVDs) captured within the Global Harmonization Task Force’s (and/or its successor organisation, the International Medical Device Regulators Forum (IMDRF)) internationally recognised definitions, and account for advances in medicine, engineering or technology.

NICE National Institute for Health and Care Excellence has published real-world evidence Guidance

National Institute for Health and care Excellence (Nice) published an guidance on framework to improve the quality of real world evidence and their use. The aim is to generate a better understanding of health and social care delivery, patient care.

USA (FDA)

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 Food and Drug Administration is proposing on its own initiative to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers, both of which are post amendments class III devices (product codes OYD and ONV, respectively), into class II (special controls), subject to premarket notification.

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