Regulation

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. […]

Though we live in countries with well-funded and advanced healthcare settings, we all know that receiving medical treatment inevitably carries risk with it. However, less is known about the procedures in place to minimise the risk of adverse events. Should I be scared to enter a healthcare setting? How do I know if the hospital where I am treated has a procedure in place to minimise risk so that it is not complicated by an infection?

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.

There are some who are claiming that the EU Commission’s formal objection to eleven standards raised at the end of last year shows that the ‘New Approach’ has shortcomings and that the whole system is ripe for overhaul. I would argue far from it. The New Approach is a very clever system of product regulation, […]

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!). […]

Eucomed published on 23 December 2010 its first Compliance Panel recommendation on the sponsorship of third party educational conferences by Eucomed members. The Panel, an independent body of three external opinion leading experts, was appointed to help provide guidance on the interpretation of the Eucomed Code of Ethical Business Practice as well as drive European harmonisation with […]

Yesterday, we, at Eucomed, had our Christmas party (Happy Christmas everybody and a big thank you to all the Eucomed members and staff for everything in 2010!!). And while thinking back at yesterday’s little get-together, it’s dawning on me that with 2011 just around the corner we will be just over two and half years since the original public consultation on the recast of the EU medical devices legislation.

In a time when much health industry focus is on the European Commission’s Health Directorate, DG SANCO, EU Commissioner for Research Máire Geoghegan-Quinn chose Covidien’s 20 year celebration of their Galway, Ireland, facility (congratulations to all at Covidien) to emphasise again the value of the Medical Technology industry to Europe and the huge policy and funding support that she and her Directorate, DG Research, provide to the sector.

Proponents of greater regulatory harmonisation and cooperation will have been heartened by FDA chief Peggy Hamburg’s comments at the Advamed 2010 conference on Wednesday 20 October. She was quick to acknowledge that, in a changing world with vastly increased trade, the FDA could not continue to operate on an old-fashioned model designed for a time […]