Getting regulation right for in vitro diagnostics and medical devices

  • Posted on 24.04.2013

Getting regulation right for in vitro diagnostics and medical devices


Serge Bernasconi

Chief Executive Officer, MedTech Europe

Regulatory revision

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.

If the scientific data isn’t enough, take a minute to hear the thoughts of Dr. Asa’ah Nkohkwo, a Technical Advisor for sickle cell disease to the UK NHS, who fears that such a system will delay sickle cell patients’ access to critical technologies and drive investors away from the sickle cell space.

But let us not think that this is the be-all and end-all of things. It is the position of the rapporteur on how the medical devices directives should be revised. However, this draft report will now be discussed with fellow parliamentarians in the ENVI Committee after which amendments can be tabled. Only then will a final version of the report be voted on in the ENVI Committee, followed by a vote in a plenary session of the European Parliament.

Scrutiny will not lead to improvements, our proposal will

Important to note, however, is that the famed “scrutiny procedure” has been deleted from the Parliament’s response to the proposal.  The medical devices industry is one hundred percent on board with the need for increased patient safety, but we do not think that Article 44, the scrutiny procedure, is going to achieve this. Eucomed has elaborated extensively on why we feel this mechanism is not going to improve security, but to sum it up for those of you with little time to read this, this, and also this and this, we fear that the scrutiny procedure will lend an air of false security to the system. That is why Eucomed proposes a systematic control procedure. This would avoid the uncertainty that comes with the proposed scrutiny procedure (how long will it take?), would happen earlier on in the approval process (not at the end) and would remove the possible competitive disadvantage (what if my innovation gets picked for scrutiny, but my competitor’s one does not?). So what do we propose?

  • Ensure that Notified Bodies (NB) assessing class III devices meet the highest quality standards by developing and implementing more rigorous criteria which NBs assessing these devices need to meet.
  • These NBs would then have to specialise to ensure they have the needed expertise to assess a specific product category.
  • Limit the number of NBs so we can increase the frequency with which they are audited.
  • Draw up and publish a list of clinical experts who will work on class III devices. All stakeholders can nominate experts to be included.
  • Ensure that NBs only work with those clinical experts that are featured in the list.
  • Require NBs to publish the names of the experts they are working with.
  • Grant access by manufacturers and authorities to these experts early in the design of a class III device

These seven measures have been chosen backed by current best practices in quality management.  We believe they will ensure the safety, quality and predictability that Europe’s citizens deserve.

As I mentioned earlier, the draft report for the IVD regulation was also released recently. Now, I have said this many times and I can’t say it enough: the separate text for IVDs gives full and official recognition to the key differences between medical devices and in vitro diagnostics.  Importantly, the draft report by rapporteur of IVD regulation, Dr Peter Liese, which was submitted for publication on 3 April, further acknowledges these specificities and ensures that the regulation remains valid and makes sense for IVDs.  It is essential that the role of IVDs in delivering accurate and crucial information regarding an individual’s health is specifically controlled, providing a balance of pre- and post-market control systems of IVDs.

Why we really need 5 years

And let me get back to this 5 year transition period I’ve been talking about. I understand that most people’s gut feeling would be to say “5 years? Why does it take you that long to execute these needed changes?” But a closer look at the whole situation would immediately reveal why it would be wise to maintain the 5-year period rather than reducing it to 3 years, as some are asking for.  Because make no mistake, the impact this revision will have on the in-vitro diagnostics industry is huge. 80% of all IVDs will be affected by it. Does it mean we are against what is being proposed? Not at all! All we are asking for is sufficient time to make sure we can properly implement these changes.

It’s a bit like writing this blog… Sure, I could do it in a few minutes, but the end result is much better when I reserve enough time to really get it just right.

Until next month,


– Serge Bernasconi, Chief Executive Officer MedTech Europe, EDMA & Eucomed

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