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The European Commission published on 1 June its long-awaited regulation proposal on European standardization. The document consists of the proposed legislative measures which update and consolidate existing EU legislation as well as impact assessments and non-legislative measures such as a strategic vision for European Standards. There were also a number of recommendations aimed at other actors in the EU Standardization system. I am convinced that these proposals are a significant step forward in the development of standards as an essential tool in developing the EU single market.

eHealth is booming, hospitals, doctors, clinics, SMEs, big companies, everybody seems to be developing an app nowadays. It is great to see how many people are throwing their weight behind eHealth initiatives in every possible way: remote monitoring of demented senior citizens by means of image interpreting software, decision support systems, …, you name it. […]

Korn/Ferry International and Eucomed are co-organising the upcoming “How to differentiate in a changing environment?” conference taking place on 5 July 2011 in Brussels. We have worked closely together to design an exciting programme that will give participants a broad view on the future from a health economic point of view, but the various sessions will also discuss what hospitals are looking for from medical device companies. In addition, we have invited accomplished speakers representing other industries’ perspectives and experiences. In short, this meeting is designed to allow the exchange of experience and ideas, and see what is done in other industries to help medical device companies enhance their competitiveness and remain healthy businesses.

When health and technology go hand in hand, safe, efficient and cost-effective solutions are often the result. Realising the immense potential that these two fields possess if they are well attuned to one another, the Commission is focussing a lot of its attention on eHealth and the benefits that these exciting technologies can bring. But not only the Commission is showing increased interest – people are talking about it, thinking about it or working with eHealth technologies.

AdvaMed and Eucomed are co-organizing the upcoming International Medical Device Industry Compliance Conference, taking place on 18-20 May in London. Both AdvaMed and Eucomed worked closely with our member companies to identify the hottest issues in medical device industry compliance today to shape a truly global, industry specific event. We also worked together to invite accomplished discussion leaders and moderators, and panel participants representing North American and European perspectives and experiences.

Medicine became evidence-based a long time ago and rightfully so. So why is it that policy decisions are, still today, far from evidence-based in Europe? Why are healthcare managers and decision makers still relying upon short-term cost containment objectives when it comes to access, regulation and evaluation of new technologies?

Everybody who has anything to do with electrical medical devices has been watching with interest the progress of the WEEE (Waste Electrical and Electronic Equipment Directive) and RoHS (Restriction of Hazardous Substances Directive) Directives through the European political process. RoHS, which should soon be published in the Official Journal of the European Union, has been especially important as the latest iteration of the Directive will see medical devices falling within its scope from about April/May 2014.

Recent events in Brussels are pointing to a fresh, healthy airing of views and more robust debate on the Recast. (By the way, I’ve noticed that everybody says ‘Recast’ but not too many people know what a ‘Recast’ is. So for all those legal and regulatory ‘techies’ among you, click here, all others steer clear!). […]

The turn of the year brings all manner of analysis of the events of one year and predictions for the year ahead. 2010 will not be fondly remembered by many as it heralded the impact of the 2008 banking crisis on the real world of citizens and business. For those in the public sector and […]