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
Optimizing EU Medtech Regulatory Governance And Innovation: First Workshop Shapes Future Study
Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.
Exciting New Opportunities Launched In UK For Innovative Products As IDAP Gets Underway
Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.
Entire EU Medtech Industry Throws Weight Behind Argument To Structurally Reform MDR And IVDR
The European Commission has conceded to the medtech industry’s calls to delay and modify the new EU regulatory requirements multiple times over the last few years. But will it yield to fresh calls for radical changes being sought by the most powerful lobby yet?
Finland’s Eurofins Becomes EU’s 11th Notified Body Designated Under the IVDR
The number of notified bodies designated under the IVD Regulation has now crept up to 11 as the first Finnish designation is announced.
Taking Steps Towards Improving Innovation Opportunities In The EU Regulatory Environment
The German notified body, TÜV SÜD, is looking to help create a more favorable regulatory environment for medtech innovation within the EU as the debate continues over damaging MDR/IVDR implementation practices.
Medtech Connect Episode 9: The Intersection Of IVDs And Digital Health
In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.