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

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

Ireland’s Medtech Keeps Calm While Trump Covets Its Healthcare Industry

The Republic of Ireland’s record in life sciences is impressive. Decades of investment, education and training have been major winners for the country’s successful economy. But its success is drawing unwanted attention from the US. Trump wants “to have that.”

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

Ireland’s NSAI reinstated under IVD Regulation designation list