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Article and Insights
The Regulatory Landscape for Medical Devices at the Close of 2023
With new laws affecting medical devices on the horizon, we discuss changes to the regulatory land...
Partner
Charleen O’Keeffe
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Article and Insights
Updates to Manual on Borderline and Classification of Medical Devices
Updates to the Medical Device Coordination Group's manual on borderline and classification of med...
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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
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Article and Insights
Medical Devices Regulation – Applicable from Today
Amidst much anticipation, the Medical Devices Regulation becomes fully applicable across the EU f...
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Article and Insights
MDR Countdown – 1 Month. European Commission Updates its Rolling Plan
With the Medical Devices Regulation (MDR) set to become fully applicable next month the European ...
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Article and Insights
Medical & In Vitro Diagnostic Devices and the AI Act: Proposed Regulatory Requirements
Artificial Intelligence (AI) is becoming an increasingly pervasive general-purpose technology, wi...
Partner
Charleen O’Keeffe
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Article and Insights
Launch of our Medical Device Publication
William Fry are delighted to launch our MDR/IVDR publication. To assist medical device companies ...
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Article and Insights
IPHA’s Revised Self-Care Advertising Code
Effective from 1 March 2021, the revised IPHA Code introduces new rules for advertising non-presc...
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Article and Insights
Guidance Published on Appropriate Surveillance under Article 120 of the MDR
The Medical Device Coordination Group has published guidance on the activities to be performed by...
Partner
Charleen O’Keeffe
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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...
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Article and Insights
EUDAMED – A Work in Progress!
New rules for the operation of Eudamed will enter into force on 19 December 2021. In this brief a...
Partner
Charleen O’Keeffe
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Article and Insights
ECJ issues Decision on SPCs for Medical Devices
ECJ rules on the availability of SPC protection for medical devices incorporating a pharmaceutica...
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Article and Insights
Surgical Robots: Are Batteries Included?
With robotic surgery now capable of being performed on a patient in one part of the world, by a ...
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Article and Insights
