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Tag: IVDR

15 news articles found
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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...

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

Reality Bites as Industry Forces Postponement of MDR Implementation

European Parliament votes to extend MDR transition periods to avoid supply shortages of medical d...

Mary Cooney
Partner
Mary Cooney
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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...

Laura Scott
Partner
Laura Scott
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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 ...

Laura Scott
Partner
Laura Scott
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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 ...

Laura Scott
Partner
Laura Scott
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Article and Insights

IVDR Crunch Time – Where does Ireland Stand?

The In Vitro Diagnostic Medical Device Regulation, (EU) 2017/746, is fully applicable as of Thurs...

Laura Scott
Partner
Laura Scott
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Article and Insights

Implementation of EU Medical Device Regulation May Face Delay

The European Commission has announced that it is working on a proposal to postpone the date of ap...

Laura Scott
Partner
Laura Scott
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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...

Laura Scott
Partner
Laura Scott
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Article and Insights

A Progressive Roll Out of the IVDR

The European Commission proposes a progressive roll-out of the In Vitro Medical Devices Regulatio...

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

Legal News – July 2022

Welcome to the July 2022 edition of Legal News. Here is a selection of our recent publications on...

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Article and Insights

Progressive Roll Out of the IVDR Confirmed by EU Parliament and Council

The European Parliament and European Council recently approved the progressive roll-out of the In...

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

Legal News – February 2022

Here is a selection of our recent publications on subjects that may affect you or your business.

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Article and Insights

Legal News – June 2022

Welcome to the June 2022 edition of Legal News. Here is a selection of our recent publications on...

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Article and Insights

What Regulatory Challenges are Facing the Life Sciences Sector?

Charleen O’Keeffe discusses some of the regulatory trends and challenges she sees coming down the...

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

Low Rate of Notified Body Designations under MDR and IVDR Causes Bottleneck Concerns for the European MedTech Industry

Continuing our series of publications, in this briefing we explore which EU Notified Bodies have ...

Laura Scott
Partner
Laura Scott