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
Final adoption of EU rules making it mandatory to register in the Eudamed medical device database as of late 2025 now looks like a formality.
The commission expects to reach its conclusions before the end of 2025. This will signal what regulatory changes the EU medtech sector can expect thereafter.
With so many regulatory developments happening concurrently in the EU at present, five forthcoming conferences promise delegates a timely update and vibrant discussions.
With so much discussion now on the need for fundamental change in the future regulation of medtech products in the EU, Medtech Insight reflects on lessons to be learnt.
The EU medtech industry is calling for an update to the decades-old rules on electronic IFU for devices. A glimpse at the listings in the European Commission’s recently released table of member state language requirements reflects how punitive the demand for hard-copy IFU can be.
Reports by manufacturers to authorities of serious incidents related to breast implants and some cardio products can now be standardized.