John Brennan

Director Regulations and Industrial Policy

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.

18 blogs from the author

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

medical devices regulation

Posted on 09.07.2012

How the approval process of medical devices works in Europe

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.

By John Brennan Director Regulations and Industrial Policy

PMA is a step backward in medical device regulation
Access Regulation

Posted on 19.06.2012

Why PMA is a step backwards in the approval approach for medical technology

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?

By John Brennan Director Regulations and Industrial Policy


Posted on 09.05.2012

So where are we again on the Revision of the MDD?

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.

By John Brennan Director Regulations and Industrial Policy


Posted on 11.01.2012

How should the EU regulatory framework change because of the PIP incidents?

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.

By John Brennan Director Regulations and Industrial Policy


Posted on 09.06.2011

Rethinking medical device manuals to save lives and trees

Useful, absent, useless or simply not up to modern communication and information exchange practices, finally I’ve just seen an honest debate on the thorny subject of instructions for use for medical devices. It seems that the seeds are being sown in the garden of England for future change to the benefit of everyone.

By John Brennan Director Regulations and Industrial Policy

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

Regulation Value

Posted on 18.11.2010

There’s a good future in (DG) Research

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.

By John Brennan Director Regulations and Industrial Policy