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
Member states reported 309 significant cybersecurity incidents affecting the healthcare sector in 2023 – more than in any other critical sector.
The European Commission has issued a report on the protectionist medtech policies in China that are impacting imports and is considering measures to protect EU manufacturers.
Despite over 27,000 individuals now named as persons responsible for checking EU regulatory compliance of manufacturers’ medtech products, there is still a lack of oversight of this comparatively new role as well as other teething issues.
Five EU documents will serve to rapidly address calls for urgent changes to the Medical Device Regulation.
“What a mess! … The MDR is a complete disaster,” critics tell European Commission.
With so many discussions around future change now in the medtech regulatory melting pot as 2025 kicks off, it is unsurprising to see an intense calendar of EU meetings ahead. But which topics deserve the most focus?