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Reality Bites as Industry Forces Postponement of MDR Implementation
European Parliament votes to extend MDR transition periods to avoid supply shortages of medical d...
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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
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
IVDR Crunch Time – Where does Ireland Stand?
The In Vitro Diagnostic Medical Device Regulation, (EU) 2017/746, is fully applicable as of Thurs...
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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...
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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...
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...
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
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...
Partner
Charleen O’Keeffe
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Article and Insights
