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
The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs
The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs
Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?
The EU’s PRRC role can differ substantially according to the circumstances at individual companies. But there is a need to further understand and shape PRRC's responsibilities so there is strong consistency across the board, PRRCs and associated stakeholders heard recently in Malaga.
Medtech engineering association shares concerns over regulations, innovation and EU competitiveness with remainder of medtech industry.
The EU medtech regulations are being targeted for change, with many amendments being critical for the sector and patients. Ireland’s Niall MacAleenan explained why tackling governance is the most critical part of this at a recent meeting in Galway.