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Posted on 12.09.2013
Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for IVDs rather than a bureaucratic quagmire. The sweeping changes being made to risk classification will be complex and time-consuming. The lessons learned from similar overhauls in other markets show us that a period of transition is essential to optimise the implementation of changes for the new European IVD legal framework.
My first blog provided the necessary insight into in vitro diagnostics and their distinguishing characteristic of never directly coming in contact with the human body. So how do they work? What differentiates them from other medical devices you hear about? The answer is that vast majority of in vitro diagnostics (IVDs) rely on biological properties and materials in order to perform as intended.
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.
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.
All about meetings and events these days: ENVI hearing, Personalised Medicine and the 2013 MedTech Forum
“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.
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.
Posted on 28.01.2013
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?”
Posted on 17.01.2013
The proposed scrutiny procedure: a measure proven to be ineffective in the world of pharma regulations
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.