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
European Commission acts on call from industry for more guidance from notified bodies around innovation.
Achieving a balance between regulatory controls and promoting innovation is proving one of the biggest challenges that the EU is facing since the implementation of the MDR and IVDR. But there are ways through.
The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.
The European Commission’s proposed timeframe for revising the MDR and IVDR is far too long, Parliament believes, and is resulting in increasingly outdated products in healthcare establishments around European threatening patient care.
Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.
Just as manufacturers need to implement corrective and preventive action plans, so this is an essential part of how a notified body functions; new guidance explains how.