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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.

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.

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.

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.

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.

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.

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.

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.