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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 devices while NSAI joins the IVDR club.
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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 from today, 26 May 2021. These Regulations represen...
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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, with AI elements in everything from our phones to ne...
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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 Thursday 26 May 2022. Together with a summary of the ke...
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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 application of the Medical Device Regulation (MDR) w...
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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 vitro diagnostic medical devices in advance of the In...
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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 Regulation (IVDR).
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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 subjects that may affect you or your business.
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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 Vitro Medical Devices Regulation. In this update...
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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
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 line with Silicon Republic.
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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 been designated under the new Medical Devices and ...
