A lifetime dedicated to passionately following medtech regulations seems a big claim, but Amanda Maxwell, regulatory affairs editor, wears the badge and has a loyal list of followers. She still remains as passionate about the implications of changing requirements as 30 years ago when analysing the drafting of the first EU medical device and IVD rules. She tirelessly picks through the draft and existing requirements and the implications of the background debate, to bring you the reality of what the latest developments and discussions mean for you. Amanda knows where to get the vital information, who can offer the best inside knowledge and how to get it to readers quickly. She is well respected in the industry and has a history of moderating and chairing at many high-profile meetings in the EU and the US ( MedTech Forum (EU), AdvaMed (US), DIA (EU and US)), and a strong network of contacts among regulators, consultants, lawyers and EU institutions. She has also been active in consulting and training companies in EU medical device regulations. Amanda has been known to pick up stories while swimming in the Aegean, and there are rumours of her renting a window cleaning scaffold outside the European Commission, but she won’t comment on this and would not recommend anyone to try it!
When not writing, Amanda is a strong well-being advocate and loves health and wellness apps. She rarely sits still and loves to be out and about, actively participating in life with family and friends.
Latest From Amanda Maxwell
National authorities can renew notified body designations by conducting reviews that do not include on-site visits, overturning one of the most critical measures introduced in medical device regulations over the last seven years.
The European Commission has at last officially requested that CEN and CENELEC develop and update urgently needed standards to support the MDR and IVDR. The pressure is now on the national European standards bodies to press on with the necessary work.
COVID-19 has meant a reevaluation of the EU of device regulations so that urgently needed devices can reach the market sooner. A commission document explains how the new system will work.
The speed to market for innovative products in the EU has been hampered because of the time it has taken to set up “expert panels” under the Medical Device Regulation. Will these products now make 26 May 2021 deadline?
While the date of readiness of the clinical investigation module of the Eudamed database is still unknown, the EU is gearing up to ensure sponsors know their obligations as soon as it comes on board.
The EU is forging ahead with designating notified bodies so that industry can become compliant with the new Medical Device Regulation as soon as possible. Mid-pandemic, we learn of Swedish designation.