72 results

Medical technology regulation

Posted on 17.01.2013

The proposed scrutiny procedure: a measure proven to be ineffective in the world of pharma regulations

If there is one thing that the medical devices industry agrees on it is that the new proposals for medical devices and IVD regulations are welcome and necessary evolution of regulation. What the industry also agrees on is that although it generally supports the new proposals, it is not certain at all that the proposed scrutiny procedure will achieve the intended goals.

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


Posted on 26.10.2012

What’s the purpose of a diagnostic test?

In vitro diagnostic (IVD) tests are likely to be a part of everyone’s life, in many cases, more than once. Yet most people do not know what these tests are or what they do.

By Lluís Bohígas Santasusagna Director, Institutional Relations, Roche Diagnostics

EU Regulation

Posted on 15.10.2012

Eucomed: proposed overhaul of EU reg system mostly positive with one caveat

The European Commission’s proposal to revise the medical device legal framework is a welcome step towards strengthening and improving the EU regulatory system. Recognised globally as being the fastest in providing life-saving technologies to patients without compromising safety, this thorough overhaul of the regulatory system seems to be mostly in line with Europe and President Barroso’s stated policy of ‘Smart Regulation’: ensuring the quality and relevance of EU legislation, which should benefit people and businesses.

By John Brennan Director Regulations and Industrial Policy


Posted on 18.09.2012

Wedding bells are ringing for the proposal of new IVD regulation

I have always found that no matter how much a person looks forward to a change, there is still that little tad of reluctance – a fear that things may not turn out for the better. The hesitation, even if momentary, manifests itself in the simple and mundane everyday tasks like clicking install for a computer software update or taking life’s big leaps, like getting married. The concern for what the change may bring is all the greater when you didn’t really mind the way things were in the first place. From my experience, some of us in the in vitro diagnostics (IVD) industry are also experiencing a bit of such reluctance when it comes to the revision of the IVD directive. Especially when it has worked fine since 1998, so why the change? A reasonable question, but considering the differences that have arisen between the healthcare context of the late 1990s and today, it’s time that our industry give the proposal careful consideration in the lead up to its approval, taking into account the impact of each of the legislation’s proposed aspects.

By Jesús Rueda Rodríguez Director International Affairs MedTech Europe


Posted on 12.04.2012

Standalone software: objects in the regulatory mirror may appear simpler than they are

January 2012 was a fruitful month for EU guidance on medical devices and produced among other MEDDEVs the MEDDEV 2.1/6 Qualification and Classification of stand alone software. This MEDDEV contains the latest thinking on how stand alone software, i.e. software that does not necessarily run on a medical device (but may have medical device functionality), qualifies as medical device under the three medical devices directives. If you are interested in a lot more background about the MEDDEV than I can provide in this blogpost (and especially nice flowcharts, which make life more simple for everyone), you can find it here.

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

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

Global Regulation

Posted on 24.03.2009

The role of EMEA in future regulation: consensus amongst experts

It was with some trepidation that I placed myself in the ‘lions  den’ of the pharmaceutical industry at the annual Euromeeting of the Drug Information Association in Berlin today. Sharing a platform to discuss the evolution of medical device regulation with Mdme Georgette Lalis of the EU Commission and David Feigal, former FDA Commissioner, proved […]

By John Wilkinson Former Chief Executive of Eucomed