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The COVID-19 pandemic has propelled the healthcare and life sciences industries into uncharted territory. We explore the flexibility of regulators ...
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A guide to the classification of devices under the new Medical Devices Regulation
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Ireland has set its sights on ensuring uninterrupted supply of medicines and assuming a greater role in EU regulatory activities post-Brexit.
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We take a look at recent guidance from the HPRA on the obligations of distributors of medical devices
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Continuing our series of publications, in this briefing we examine the key changes to the regulatory pathway for drug-device combination products (...
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Continuing our series of publications, we outline the key changes to the classification of in vitro diagnostic medical devices in advance of the In...
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In this article, we consider the current status of registration requirements for economic operators and devices under the Medical Devices Regulation.