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7 news articles found
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Article and Insights

Regulatory Flexibility – Key Measures to Support Availability of Medicines and Medical Devices During COVID-19

The COVID-19 pandemic has propelled the healthcare and life sciences industries into uncharted te...

Charleen O’Keeffe
Partner
Charleen O’Keeffe
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Article and Insights

Medical Devices – New Classification Rules – Is your Business Ready?

A guide to the classification of devices under the new Medical Devices Regulation

Charleen O’Keeffe
Partner
Charleen O’Keeffe
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Article and Insights

Ireland and the European Medicines Agency Prepare for Brexit

Ireland has set its sights on ensuring uninterrupted supply of medicines and assuming a greater r...

John Sugrue
Senior Associate
John Sugrue
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Article and Insights

Guide for Distributors of Medical Devices – A “Must Read” For All Distributors

We take a look at recent guidance from the HPRA on the obligations of distributors of medical dev...

Laura Scott
Partner
Laura Scott
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Article and Insights

Drug-Device Combination Products: Where do they fall within the new MDR Regime?

Continuing our series of publications, in this briefing we examine the key changes to the regulat...

Charleen O’Keeffe
Partner
Charleen O’Keeffe
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Article and Insights

Act Now to be Ready on Time – Guide to New Classification Rules for In Vitro Diagnostic Medical Devices

Continuing our series of publications, we outline the key changes to the classification of in vit...

Charleen O’Keeffe
Partner
Charleen O’Keeffe
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Article and Insights

Registration Requirements under the Medical Devices Regulation – Where Do We Stand?

In this article, we consider the current status of registration requirements for economic operato...

Charleen O’Keeffe
Partner
Charleen O’Keeffe