Amanda Maxwell
Managing Editor
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
EU: Good News For IVDs And For Future Transparency Of Medtech Compliance
The IVD industry has long been awaiting a further extension of the deadlines for compliance with the IVD Regulation and for the launch date of the Eudamed database to be brought forward.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.
First Danish Notified Body Named Under EU's Medical Device Regulation
The EU now has a total of 45 notified bodies under the MDR.