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.
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Latest From Amanda Maxwell
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.
In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.
The EU Medical Device Regulation threatens the viability of many premarket innovators and SMEs in the UK, and across Europe. Eithne Lee, of ISO Life Sciences global consultancy, explains how the new requirements come as a shock for many small companies, how many are ill-prepared and how the cost of compliance relative to turnover may be too high. This is part one of a two-part article.
With just three months and three weeks until the full application of the EU Medical Device Regulation (MDR) on 26 May this year, a tenth notified body has been designated under the regulation.
Brexit could hardly have come at a worse time for the medtech sector in Europe. The implementation of the new medtech regulations is behind schedule, and threatening the survival of many medtech products. Now the UK is looking at its own regulatory route. Will this mean regulatory divergence?