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.
Industry associations support the commission’s MDR/IVDR revision simplification objective and aim to increase Europe’s competitiveness, but MedTech Europe also sees further room for improvement.
The just published proposed targeted revision of the Medical Device and IVD Regulations is a radical rethink of how the EU should regulate medical devices. The document is aimed at supporting industry and patients alike.
New document sets out a structured framework to help breakthrough medical devices tackling serious health needs navigate EU regulation with greater clarity, collaboration and predictability.
Just ahead of the European Commission publishing its proposed revisions of the Medical Device and IVD Regulations, it has released an equally important document on the future of notified body operations in the bloc.