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Nowadays everyone seems convinced of the clinical benefits that medical technologies, devices and diagnostics, bring to the table. Many even recognise that our innovations bring about considerable socio-economic benefits. And yet, in the end I hear the same thing over and over again: medical technology drives the rise in healthcare expenditure.
EDMA and Eucomed have always refuted this claim and now we have research by the European Health Technology Institute (EHTI) which basically confirms two of our points of view:

My journey at the European industry association Eucomed started two and a half years ago. During my interviews for the communications role I was made aware that the medtech industry was facing new European legislation and that the process was underway. Never did I expect the need for a forceful modern communications campaign. I’ve been trained professionally by a global communications consultancy firm which teaches you to be an honest devil’s advocate when advising clients. So during the last couple of years at Eucomed I’ve been able to ask many critical questions about industry’s suggestions for the new regulatory framework.

Many times I’ve found myself in situations where I had to explain that indeed in vitro diagnostics (IVDs) are to all extent medical devices but that, in practice, the subject we happened to be discussing would not entirely (or at all) be applicable to IVDs.
It was always a case of: “…yes, yes.. BUT”…
If there is one message you take away from this post, let it be… IVDs have very different risk sets associated to them: no direct contact with patient, value of the medical data they deliver and that they provide no treatment.

First off, let’s start with some background. The first question that comes to mind would be: “What is the EUnetHTA Joint Action 2?” Briefly put, EUnetHTA, the European Network of Health Technology Assessment, is a joint initiative of the European Commission and the relevant agencies in the Member States, aiming to strengthen cross-border HTA collaboration.

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.

This week a very interesting group of people met on the last day of the ESC Congress (European Society of Cardiology) in Munich. Representatives of the Eucomed CRM Telemonitoring Working Group, individual member companies and leading representatives of the ESC came together under the chairmanship of the European Heart Rhythm Association (EHRA) to officially launch the White Paper “Moving towards good practice in reimbursement of CIED Telemonitoring”.

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:

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.