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
The EU IHI’s eighth call for action also encourages innovative medtech approaches to tackling cardiovascular disease and osteoarthritis and patient-centered endpoints that can benefit from advancements in digital health.
Two years after the EU adopted the original common specifications for certain products under the IVD Regulation, the commission has added new products and updated its requirements.
Any apps, or indeed any software, which assist communication in the medical field need to be carefully evaluated against a tricky-to-comprehend rule in the EU’s Medical Device Regulation.
When a medtech regulatory consultant receives some 500 requests in a single month on LinkedIn for a guide he has spent 300 hours writing, you know it is a critical topic.
At last, there is more transparency for medtech manufacturers about testing and certification costs. But BSI is still the only notified body to have published lead times under the medtech regulations.