46 results

Business Regulation

Posted on 03.11.2011

What did Europe ever do for us?

As the Euro zone crisis threatens to precipitate a much more fundamental questioning of the European dream, it is easy to revert to the eurosceptic homeland of vilifying apparently meaningless rules and regulations that have little real impact on the lives of any of us. The likes of the British ‘save our pint’ campaign trivialises the debate and does little to educate the voters of member states as to the real issues at stake.

By John Wilkinson Former Chief Executive of Eucomed

My tmixing HTA with regulation
Global Regulation

Posted on 17.08.2011

My thoughts on mixing HTA with regulation? The writing’s on my wall…

Not too long ago, I was invited to a friend’s 40th birthday party. As many other guests I came up with my best wishes and cheers stressing the benefits of getting “settled, mature, wise, stable, change-resistant and risk and-averse…” That was then, but it did make me think when today I was once again reading through the WHO report “Health Technology Assessment of Medical Devices” how ambiguous this whole age perception is.

By Victoria Malakhova Former Eucomed Director Economic Affairs

Digital Regulation

Posted on 07.06.2011

eHealth applications and websites developed by clinicians: there are rules for that!

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. […]

By Erik Vollebregt Life Sciences and IP Lawyer, and Founding Partner Axon Lawyers

Regulation Value

Posted on 15.02.2011

The ‘New Approach’ – making standards even better

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, […]

By Andy Vaughan Eucomed Environment Consultant

debate brussels

Posted on 08.02.2011

Brussels starts healthy debate on Medical Device Recast

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!). […]

By John Brennan Director Regulations and Industrial Policy


Posted on 17.12.2010

You better watch out!

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.

By John Brennan Director Regulations and Industrial Policy

Global Regulation

Posted on 21.10.2010

Can we move global harmonisation to the next level?

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 […]

By John Wilkinson Former Chief Executive of Eucomed


Posted on 14.04.2009

One of the great untold strengths of device regulation in Europe

Just back from Easter holidays and picked up this article from the Wall Street Journal “Medical Devices Face New Scrutiny From FDA”.  When I read the article it reminded me again of one of the great untold strengths of device regulation in Europe and yet another example where the European system is better than the […]

By John Brennan Director Regulations and Industrial Policy

Access Regulation

Posted on 07.04.2009

More from the DIA EuroMeeting 2009

From 23 – 25 March 2009, the Drug Information Association (DIA) held its annual EuroMeeting in Berlin. During the presentation by Richard Moore, Institute of Nanotechnology, I learned that prescription drugs prove to be ineffective in 30% – 60% of patients1 and that 16% of the drugs approved in the USA are linked to severe […]

By Dario Pirovano Consultant Regulatory Affairs