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Article and Insights
Commission Revamps MIR Form for MDR and IVDR Compliance
In May 2025, the European Commission released a new version of the Manufacturer Incident Report form, with mandatory compliance required by Novembe...
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Article and Insights
Unlocking Health Data: The European Health Data Space
The European Health Data Space Regulation is set to transform how health data is accessed and used across the EU. This article outlines key obligat...
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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 landscape.
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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 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 & 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
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 Commission has published an update to its Implemen...
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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 navigate the new MDR & IVDR regulatory regime we h...
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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
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 notified bodies as part of their ongoing surveill...
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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 regulatory pathway for drug-device combination products (...
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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
A Stricter Regime is Beckoning for Manufacturers of Popular Beauty Devices
The European Commission has proposed reclassifying certain beauty and brain stimulation devices without an intended medical purpose under the Medic...
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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
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
Registration Requirements under the Medical Devices Regulation – Where Do We Stand?
In this article, we consider the current status of registration requirements for economic operators and devices under the Medical Devices Regulation.
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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 ...
