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Amanda Maxwell

Managing Editor

London, UK

Amanda is EU medtech regulatory affairs editor at Medtech Insight. She has been reporting and providing analysis on developments in the field of medical technology regulatory affairs, with particular focus on the current and future EU regulations for medical devices, IVDs and device/drug combination products since the mid-1980s. She monitors and reports on all aspects of the implementation of the EU’s Medical Device and IVD Regulations, including relevant guidances, standards, expert opinions and ongoing challenges for all players in meeting the new requirements.

Her features have appeared in a variety of in-house publications and services. She also wrote medtech regulatory country profiles for Citeline’s former EU Law service and regularly contributes to In Vivo. Amanda regularly interviews experts in the EU medtech regulatory space and publishes interview podcasts. She also has experience in providing medtech regulatory strategy consultancy services, is often invited to speak and chair at EU meetings on medtech regulations and drug/device combination regulatory issues and is a frequent advisor to conference organizations.

Amanda enjoys taking part in LinkedIn discussions, has a background in the language and literature of Italy and France, and a passion for being part of the EU scene.

Latest From Amanda Maxwell

Crucial Council Of EU Debate On Medical Device Regulation Crisis Countdown

The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.

EU Europe

Reclassification Of Active Annex XVI Products Now Official

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

EU Europe

European Regulatory Roundup, November 2022: EU MDR Situation Now Critical

Damage limitation action is expected imminently to try and stem the flow of medtech products being taken off the EU market. And it cannot come quickly enough as evidence continues to mount of the negative fall-out resulting from the way the EU’s new medical device regulations have been, and are being, implemented.

EU Europe

EU Designates First Czech Notified Body Under MDR

The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.

Europe EU

First Revision Of EU Medtech Standardization Mandate Due Early 2023

Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.

EU Europe

MedTech Europe Calls For EU To Amend Regulation To Allow For eIFU For Low-Risk Devices

The EU needs to go further when it comes to allowing the use of electronic IFU for all professional use medical devices and fall more closely into line with other global markets.

EU Europe
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