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 Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict sharing of their information.
MedTech Europe Calls For Swift Answers In Areas Where AI Act Threatens MedTech
With the EU AI Act close to being finally adopted, industry is now calling for guidance and clarification to prevent the new legal text complicating the regulation of medical devices and diagnostics and putting obstacles in the way of patient access to innovation.
40% Plus Growth In Notified Body Certificates Issued Under EU Medtech Regulations
After years of concern over notified body ability manage the volume of conformity assessment applications from medtech manufacturers, there is evidence that capacity has increased significantly, and this is showing results.
Harmonized Standards Under Medical Device and IVD Regulations Trickle Through
Two new sets of standards have been officially recognized under the MDR and one under the IVDR. But progress is slow, and the numbers of standards updated remains exceptionally low nearly seven years after the regulations were adopted.
US Group Supports EU Industry Concerns Over Revised Liability Laws
US industry, well acquainted with how damaging a litigious culture can be, warns EU over the impact of its Product Liability Directive on medtech and other sectors.
US Chamber Of Commerce Announces 5-Year Mission To Address Fundamental EU Problems
The European Commission can expect the US industry to be an active partner when it takes stock of its medtech regulations, given AmCham EU’s latest mission and vision for the EU.