Amanda Maxwell

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

Fragmented Governance Must Be Tackled As Part Of EU Medtech Revision

Industry associations support the commission’s MDR/IVDR revision simplification objective and aim to increase Europe’s competitiveness, but MedTech Europe also sees further room for improvement.

Commission’s Device Regulation Revision Promises 25%-35% Cost Savings For MedTech

The just published proposed targeted revision of the Medical Device and IVD Regulations is a radical rethink of how the EU should regulate medical devices. The document is aimed at supporting industry and patients alike.

EU’s Breakthrough Technologies Guidance: A Milestone For Medtech Innovation

New document sets out a structured framework to help breakthrough medical devices tackling serious health needs navigate EU regulation with greater clarity, collaboration and predictability.

All Change For Notified Bodies: Moving Towards A More Highly Regulated Future

Just ahead of the European Commission publishing its proposed revisions of the Medical Device and IVD Regulations, it has released an equally important document on the future of notified body operations in the bloc.

Latest Regulatory Updates From The EU As Change Is In The Air

A new face seconded to the European Commission's medtech unit and changes to several EU rules impacting medtech

New Opportunities For Coordinated EU Review Of Device/IVD Investigations As EU Builds New System

Sponsors of higher risk device and diagnostic investigations are being invited to participate in a pilot that aims to reduce regulatory burden.