71 results


Posted on 25.07.2012

The impact of WEEE2 on the medical devices industry

The long anticipated revision of the Waste Electrical and Electronic Equipment (WEEE2) Directive (2012/19/EU) was published in the Official Journal, L197, on the 24th of July 2012. The Directive arrives just over a year after its sister Directive 2011/65/EU on the Restriction of Hazardous Substances (RoHS2). The stated aim of WEEE2 is to:

By Andy Vaughan Eucomed Environment Consultant

HCP relationship

Posted on 16.07.2012

Transparency in the HCP-Industry relationship: supporting industry efforts with an effective legal framework

For the medical technology industry, collaboration with healthcare professionals (HCPs) is an absolute must. HCPs are prime users of new technology and play an instrumental role in the successful diffusion of innovative medical devices throughout Europe. In fact, HCPs often bring the ideas to the table that lead to the development of new devices and inspire continuous incremental improvements to existing technology.

By Peter Dieners Head of Global Healthcare, Life Sciences and Chemicals Sector Group, Clifford Chance

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

medical device labelling

Posted on 02.07.2012

Toward the best possible solution in EU medical device labelling

In summer of 2011, the EU’s Central Management Committee’s (CMC) published “Decision No 3”, requiring the placement on medical devices of the full postal address of manufacturers and authorised representatives. Since then, Decision No 3 has had the European medtech industry scratching its head in confusion. As we see it, the adoption of the decision has already led to great legal uncertainty, and implementing it in its current form would serve only to increase bureaucracy and additional, unnecessary costs.

By Merlin Rietschel Manager Regulatory & Technical Affairs, Eucomed


Posted on 26.04.2012

Ethics and compliance in the MedTech industry: on the agenda in Stockholm

For medtech companies, interacting with Healthcare Professionals (HCPs) is a fact of life. HCPs are an integral part of the R&D process and a source of innovation and creativity throughout the development of medical devices. HCPs are also the prime users of technologies and play an instrumental role in the successful adoption of innovative medical devices in Europe, the US and beyond. With the adoption of new anti-bribery laws in a number of countries, increasing enforcement and new pressures from investors and the general public, the International Medical Device Industry Compliance Conference on 9-11 May in Stockholm, is well-timed to provide a platform for stakeholders to discuss these mounting challenges.

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


Posted on 28.02.2012

Assessing the value of medical devices – it’s about more than just clinical effectiveness

Ever since the end of WWII, the reigning clinical philosophy was one whereby there was no limit on medical treatment. From the 80s onwards, this philosophy shifted towards a more balanced approach whereby the benefit of the treatment had to outweigh the potential risks associated with it, with evidence-based medicine being the concept used to assess a new treatment.

By Yves Verboven Director Market Access and Economic Policies, MedTech Europe


Posted on 27.01.2012

Launch of first conference vetting system: getting closer…

In October last year, Eucomed published a press release to introduce to its broader membership and stakeholders the launch of a new “Conference vetting system” in 2012. Aimed to simplify decision-making for Eucomed members by providing clear approvals on sponsorship of events, this unique initiative in our industry has already interested the media, including an article in the Financial Times.

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

Silver linings

Posted on 17.01.2012

On clouds and silver linings: Leadership transition at Eucomed

Most of you know that John Wilkinson has left the position of Eucomed Chief Executive at the end of last year. And even though John’s decision was announced already in June of 2011, as I write this now, more than six months later, it still feels as if he informed me of his intentions only yesterday. Fond of the Brussels bubble while at the same time being excited about the European and global perspective of the job, I am sure it was by no means an easy decision.

By Guy Lebeau Chairman of the Eucomed Board

EU Medical technology

Posted on 06.09.2011

Medtech industry must change its way of doing business to remain successful in the EU

Europe is an important and continuously growing market for medical technology products. Driven by budgetary pressure on the payer and provider levels as well as by strong competitive dynamics, the commercial climate for established medical technology companies is, however, deteriorating. The recent industry survey MedTech Barometer 2011 conducted by us (and with ‘us’, I mean global strategy and marketing consultancy Simon-Kucher & Partners) confirms the presence of increasing commercial challenges but still provides an overall positive short-term business outlook. Yet the longer-term outlook is less positive and suggests that in order to remain successful in the European market place, established players will have to adapt their way of doing business in the future.

By Joerg Kruetten Executive Vice-President at Simon-Kucher & Partners and head of the Medtech competence center