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
MDR Amending Regulation Officially Published And Already In Force
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.
Time For Talking: MedTech Europe Wants Clarity And Transparency Over MDR Amendment
The MDR amending regulation is on the cusp of being enforced. Most feel it is long overdue to prevent further medtech regulatory chaos in the EU. But the new text raises many questions itself. Medtech Insight spoke to MedTech Europe’s Petra Zoellner to understand what is needed next.
TEAM-NB Membership Increases By Over a Quarter Within Six Months
TEAM-NB was originally created to raise standards among notified bodies to an agreed harmonized level. Its latest expansion aims to continue that mission of spreading best conformity assessment practices.
Official Sign-Off For EU Medical Device Regulation Amending Text Due Today
The first legal stages in the process for implementing new rules that will extend the Medical Device Regulation transitional period and remove the one-year sell-off period conditions are nearly complete. But further work will be needed.
Stack Of New And Revised EU MDR and IVDR Guidances In The Pipeline
The EU has published a lengthy list of new guidances to be drafted as well as existing guidance documents that need updating in the context of its MDR and IVD medtech regulations, including covering the interpretation of the Medical Device Regulation wording on “significant changes.”
France’s Snitem Demands Shock Cardiac Devices Reimbursement Decision Be Reversed
French medtech trade association, Snitem, and local cardiologists are stunned by the removal from the reimbursement list of two state-of-the art cardiology devices and are demanding their reinstatement.