John Brennan

John Brennan is currently the Director of Regulations and Industrial Policy at MedTech Europe. John joined Eucomed in August 2008 as Director of Technical & Regulatory Affairs, after spending five years at the European Commission working in the Unit responsible for the European medical devices legislation. During his time at the Commission he also had particular experience in international regulatory cooperation (GHTF). John has over 20 years experience both on the regulatory and the industrial sides of the healthcare industry.

I think that United States Secretary of Defence Donald Rumsfeld was completely clear when he gave his now famous answer to a question at a U.S. Department of Defence news briefing back in 2002. It was about the lack of evidence linking the government of Iraq with the supply of weapons of mass destruction to terrorist groups. He said “Reports that say that something hasn't happened are always interesting to me, because as we know, there are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns -- the ones we don't know we don't know. And if one looks throughout the history of our country and other free countries, it is the latter category that tend to be the difficult ones.” Crystal clear then. You may disagree but I know what he was getting at. Just take a look at what is ahead of us in the MDD revision in 2015 for example.
EU Regulation
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.
medical devices regulation
Last month I wrote a blog on pre-market authorisation (and why this approach does not work for devices!) and thought it would be a good idea to just lay out how the European approval process for medical devices actually works. It might be a bit ‘dry’ but at least after reading this post you’ll understand the mechanics of the European system.
PMA is a step backward in medical device regulation
Lately I hear and read a lot of people asking for a Pre-Market Authorisation process for medical technology in Europe, or PMA process as it’s known, similar to the one in the US. Even the European Parliament voted (narrowly) for a resolution in which they call for a PMA approach. And that made me think, hold on a second, don’t we already have an approval system in Europe for high risk products?
There has been so much media and political focus on the medical device legislation in Europe in the first four months of 2012 that one could be forgiven for losing track of what's exactly going on and where we are exactly in the process.
Change
Since the French authorities made their announcement just prior to Christmas, the PIP case has generated a large amount of press and political attention. Quite rightly, the main focus is on the women affected and on governments providing the right health advice and appropriate follow-up. As I am writing this posting a couple of days after we released our first statement, I understand that the European Commission is to seek an independent scientific opinion on the human health risks of silicone breast implants.