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
The latest EU designation means Germany now has six notified bodies under the MDR and Italy only one.
This is the busiest time in the history of notified bodies as they try to process all manufacturers under the EU Medical Device Regulation (MDR). Making use of MDSAP audits is one way to cut down on work but is not always an option. The EU’s latest guidance explains the detail.
The MHRA has updated its guidance on regulatory flexibilities for medical devices and medicinal products resulting from COVID-19 to highlight how its approach differs from the EU.
Despite the publication of a flurry of guidance documents over the last couple of months, there have been delays in implementation tools needed for the full application of the Medical Device Regulation, which will make compliance harder for the sector to achieve.
The European Commission’s output of guidance documents over the last few months has been extraordinary, and unprecedented. A new website gives users access to all these documents and shows what has changed.
Between 15 April and 5 July, the VentilatorChallengeUK consortium delivered 13,437 ventilators to the UK NHS. How was this achieved? And what is the UK learning about the way devices should be regulated in the future?