84 results


Posted on 04.05.2011

How we in the U.S. see global compliance challenges for MedTech companies

AdvaMed and Eucomed are co-organizing the upcoming International Medical Device Industry Compliance Conference, taking place on 18-20 May in London. Both AdvaMed and Eucomed worked closely with our member companies to identify the hottest issues in medical device industry compliance today to shape a truly global, industry specific event. We also worked together to invite accomplished discussion leaders and moderators, and panel participants representing North American and European perspectives and experiences.

By Christopher White General Counsel, AdvaMed

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

Business Regulation

Posted on 10.01.2011

Panel-mania? The future of an advisory interpretation

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 […]

By Aline Lautenberg MedTech Europe, General Counsel - Director Legal & Compliance


Posted on 04.11.2010

Investing in education: Redefining strategy?

Any conference, congress or other important event usually involves some kind of a feedback exercise.

By Aline Lautenberg MedTech Europe, General Counsel - Director Legal & Compliance


Posted on 01.10.2010

Adam Smith, corruption and biases

The 7th European Healthcare Fraud & Corruption Network conference took place in Brussels at the end of September and featured high level speakers and experts. The event proved to be an ideal platform for discussing a number of topics of relevance to all the stakeholders in the healthcare system. The “Conflicts of Interest” session was […]

By Aline Lautenberg MedTech Europe, General Counsel - Director Legal & Compliance

Ethics Global

Posted on 29.03.2010

Is corruption an ethnocentric concept? My first experience as a guest lecturer

Talking about ethics and compliance as industry understands it within the frame of a course of Health Systems Management given at the Public Health School of the Université Libre de Bruxelles (ULB) presented itself as a challenge. On the one hand, Eucomed is putting a lot of efforts into promoting a culture of integrity and […]

By Aline Lautenberg MedTech Europe, General Counsel - Director Legal & Compliance

Regulation Value

Posted on 18.11.2009

EU device database set to become a reality

On the 29th October all the votes were in and it seems that nothing more than EU paperwork stands between us and our first compulsory European database for medical devices, the infamous ‘Eudamed’ database. I say compulsory because ‘Eudamed’, as our European device database is known, has been in place for many years, but it […]

By John Brennan Director Regulations and Industrial Policy


Posted on 29.10.2009

Waste and paying for tomorrow’s healthcare

Yesterday’s report by Thomson Reuters on the real causes of excessive costs in the US healthcare system make interesting reading. Centre stage is over-treatment generated by a litigious culture which encourages patients to sue and, from that, doctors to perform tests and procedures, not because in their clinical judgement the patient needs them but because […]

By John Wilkinson Former Chief Executive of Eucomed