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Caveat Emptor, or ‘Buyer Beware’, is a commercial rule favouring the seller, now largely extinct due to modern consumer legislation. But the European Parliament’s ENVI Committee, in its amendment on the reprocessing of single-use medical devices, has unwittingly slipped something similar back in again. Given the complex and highly technical nature of the Medical Devices Directives, I can see where busy MEPs would struggle to understand the details and consequences of this amendment, so I think it is essential that we take a moment to read the fine print.

Europe’s medical device industry has always agreed that Europe’s regulatory system for devices needs to be improved and has put forward various proposals to achieve this. In the wake of a case of fraud like the PIP breast implant incident, it is clear that we need a safer system that makes sure Europe’s patients continue to have timely access to the latest life-saving and life-enhancing medical technologies.

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.

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.

It’s been a busy two weeks at the Parliament once again, with the release of both the draft report for the revision of the Medical Devices Directives (MDD) and that for the In Vitro Diagnostics Directives (IVDD) revision. Last Monday, EU Parliament Rapporteur Dagmar Roth-Behrendt published her draft report on the revision of the MDD. Although not surprised, we of course regret to see proposals such as a shift to centralised pre-market authorisation. This US-like system will not bring about the necessary additional patient safety and actually risks hindering patients in their access to lifesaving devices because of unnecessary delays in these devices becoming available to them.

By now most of you will have noticed that we have launched our “Don’t Lose the 3”-campaign. (If you haven’t, watch the 1-minute video and patient stories here. The basic message of the campaign is that, thanks to our decentralised approval system for medical devices in Europe, Europeans have access to life-saving and life-enhancing technologies three to five years before US patients without compromising safety. This is also the message I brought forward during the 26 February hearing of the ENVI committee at the European Parliament.

The upcoming MDD revision can learn a lot from a 2007 mistake in woundcare regulation.
Burn wounds result in some of the most horrific pictures one can come across as a surgeon. Burn victims not only have to suffer the immediate pain associated with burn wounds, but also have to deal with often permanent scar tissue, a lifelong reminder of that terrible moment.

“First one down”… And I have to admit that I was pleased to read all your positive feedback and comments. This really gives me the enthusiasm to do even better in this second blog. If there is one thing I’ve learned from this whole process, it is that starting a new blogpost is like having to wake up in the morning: at first when the alarm is still buzzing you wish you didn’t have to, but once you get that first leg out of bed, you’re happy you did and everything else sort of follows from that first step.

Only a few days ago, I heard those words for the first time. Me? Writing a blog? Hmmm, ok, there could be an opportunity here… And now I am looking at a blinking cursor inviting me to put down a few thoughts and ideas.
Well, why don’t I start by answering a few questions “Why now? Why not 3-4 months ago, Serge? How often can we expect to read your posts? And what will you be talking about?”