Eucomed LifecycleSerge Bernosconi is CEO of Medtech Europe, Eucomed and the EDMA. Medtech Europe is the umbrella organisation for Eucomed and the EDMA. Eucomed is Europe's medical device industry association and the EDMA, the European Diagnostics Manufacturers Association, is the association for Europe's diagnostic device manufacturers.
Eucomed CEO, Serge Bernasconi, has written a blog about the current regulatory changes in Europe ahead of that organisation's conference in Belgium in October. The blog is reproduced below with kind permission from Eucomed.
"Judging by the weather in Belgium (currently 10° and raining) you wouldn’t say it, but it’s almost summer. Well, at least according to the calendar. And apart from the supposed good weather, summer also brings with it a host of new information on the MedTech Forum. Speakers are being confirmed, registrations coming in and preparations being made. Less than 5 months from now, we will all be seeing each other again at the event no one in our industry can afford to miss. So what does the MedTech Forum hold in store this year.
The 2013 theme of the MedTech Forum is “New rules. New Markets. Medical Devices and Diagnostics’ place in a changing Europe.” For anyone “au courant” (pardon my French)of what’s happening around Rond Point Schuman, this theme does not come as a surprise as it basically encapsulates what we at EDMA, Eucomed and MedTech Europe have been focussed on ever since both revisions were still called recasts.
Under this umbrella theme, we decided to focus on three topics which you not only told us are of high interest to you, but will impact our industry vastly in the coming years. Speaking of topics which are of interest to you… when my communications team tells me which news items in our newsletter are most read, which blogposts are most visited or which videos most watched, it is clear that the revision of the IVDD (In Vitro Diagnostics Directives) and MDD (Medical Devices Directives) are what is crucial for many of you. Recognising this, we have dedicated a substantial part of the event to both legislative frameworks. Expect a plenary session focussed on clinical evidence, expect an MDD and IVDD workshop on the impact of the revision on business, and of course much more.
Regulation is a hugely important factor in determining whether or not our industry can maintain its leading role in innovation in Europe or not. This is not only important for us, but also for Europe and its citizens. Because innovation will be crucial to ensure the sustainability of Europe’s healthcare systems in the future. And we as manufacturers or medical technology have an important role to play in that. How we contribute and what we will do concretely to play our part is laid out in our 5-Year Strategy “Contract for a Healthy Future”, and it is this strategy which will be at the centre of many a session at the MedTech Forum. In fact, the CEO roundtable will be all about the Industry Strategy, and will outline the achievements of the past 2 years and what we can look forward to in the next few years. Regulators and purchasers will discuss the relation between innovation and healthcare sustainability and how the Contract can help in building more sustainable healthcare systems.
The third topic of the event will revolve around Emerging Markets. And we’ve got some excellent speakers from PwC lined up to tell you all about successful emerging markets entry strategies in Europe. Chris Wasden gave an eye opening presentation 2 years ago at the Forum where he introduced the Global Innovation Scorecard, which assesses countries’ capacity and capability for medical technology innovation. PWC updated its research and will present the new results, including the difference between technology needed in mature and emerging markets, in a plenary session and a workshop session.
If you are planning on attending the MedTech Forum, you really shouldn’t wait too long to register. Not only does the early bird discount expire on 1 July, but seats for the various workshops are filling up fast, and there are only limited seats available. Some workshops are already sold out! So head over to www.medtechforum.eu to get the latest programme, see who else is attending and save your spot.
From an event that still has to take place over to one which just took place last week – the MedTech Compliance Conference. Hosted in beautiful Warsaw this year, the joint AdvaMed-Eucomed organised event saw a record number of 227 participants. Clearly, the new concept of “Coffee Tables” whereby several topics are discussed in small groups of people proves to be very successful. Also a first this year was the much broader geographical nature of the event with speakers from Russia, China, the Middle East and Australia to name a few.
One of the topics discussed at the conference was financial disclosure requirements (aka "Sunshine"). The timing could not have been better as the French Sunshine Law decree was published earlier this morning. More information this Friday in our newsletter.
If you were not able to make it this year, make sure you do not miss next year’s event from 20 to 22 May in Barcelona, Spain. There simply is no other compliance event of its kind which offers these opportunities for networking and leaves participants with usable takeaways they can immediately apply in their professional activities.
Another thing I wanted to bring to your tech-savvy attention is the launch of LabTest Online(LTO) UK’s smartphone app. My tech people told me it is available for free for both iPhone and Android devices and allows you to look up all LTO UK information, even while you’re on the go and without an internet connection.
And as this blog draws to a close, so does our time at Place des Maïeurs. To be able to speak with a strong voice and deliver our message effectively, it is critical that we are among our stakeholders each and every day. In that respect, moving offices closer to our stakeholders is the right “move” , for instance to keep a close eye on the 1307 amendments that were proposed by MEPs to both the MDD and IVDD texts. And I am very excited to announce that starting Monday 17 June, you can find us on the 1st floor of Rue Joseph II, 40 in 1000 Brussels. To celebrate our new offices we will put together a housewarming reception in September. The exact date will be announced shortly so keep an eye on your mailbox for more information."