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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

Why Notified Bodies Are Now The Focus Of Centralized Oversight Efforts

Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.

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Oliver Bisazza Warns That EU’s Innovation Issues May Create More Reliance On Medtech Imports

Innovation has been hindered in the EU by the costs and complexities of compliance, including in the medtech sector. Bisazza looks at how high-level, multi-sectoral moves are underway to create a more innovation-friendly environment.

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Amendment To MDR May Be First Legislative Proposal Of New European Commission

How Germany, which has the EU’s largest medtech manufacturing base, is pressing for the MDR to feature on the mission letter for the new European Commission and could influence the pace of change.

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Europe Must Take Temperature Of New EU Institutions Before Next Medtech Initiative

MedTech Europe's Oliver Bisazza reflects on how European election outcomes may influence medtech regulatory strategy

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How The European Parliament Seeks To Amend The MDR: A Step-By-Step Guide

Medtech Insight has already focused on six of the key changes in the parliament’s proposal to the European Commission. This article looks in further depth and breadth at the changes which, if taken up, are designed to ease the regulatory burden in the EU, support SMEs and innovation. and result in fewer products being removed from the market.

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MDR/IVDR Amending Document Finally Adopted

In this amendment to both the Medical Device and IVD Regulations, the IVD Regulation timelines will be eased and Eudamed will be rolled out before the entire database is ready.

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