February 26, 2014
The European Commission released its proposal for the revision of the EU Medical Devices (MDD) and In Vitro Diagnostics Directives (IVDD) in September 2012. The European Parliament weighed in the file, voting on its final report in a plenary session last October. And in December we heard reps from the 28 EU health ministries voice their views on key issues. The word on the street is that the EU Council is set to reach its final position by June with trialogue discussions (where the Commision, Parliament and Council negotiate a final text) pencilled in for Q4 2014.
So on this 26th of February, I’m afraid I have no news to break although a lot is going on behind the scenes. And, given the complexity of the MDD and IVDD files, I thought I might take moment to review the key issues from a medtech industry perspective and clear up any confusion.
Diagnostics: Three years is really too short
On the IVDD side, the suggested transition three-year transition period continues to worry us. Three years is simply not enough time for all involved players to adapt to what are really sweeping changes across the system. We’re not talking only manufacturers (and importers) but also Notified Bodies, Competent Authorities, reference laboratories and the European Commission who will need to manage the changes in three years. Implementing changes over five years is tough, but it is a more feasible scenario, one that all involved players can fulfill with effort and dedication. I believe that if we go for a three-year transition period we will probably encounter a request for an extension after two and a half years in the process.
Yet despite the sweeping overhaul, many of the proposed changes are welcomed as they will improve global competitiveness of the European IVD industry and facilitate access to new technology for patients. Implementing a classification model that is harmonised with international standards, for example, sets the scene for comparing relevant data on a global level and improving vigilance. This is a critical aspect for enhancing patient safety and one that should, after all, be at the core of the legislative changes.
As the industry, it is up to us to ensure that the tests used to diagnose patients, monitor health status, screen or assess predispositions are accurate and safe; policymakers, on the other hand, must consider that IVDs never come into direct contact with patients, fundamentally distinguishing them from other medical technology and impacting how they should be controlled. It is only in working together, we have the opportunity to truly create a regulatory system that helps patients, safeguards SMEs and improves European innovation.
Devices: The key issues as industry sees them
We’ve spent the past several months communicating our views on many MDD-related issues, but four of them have emerged as particularly important. First off, we feel that the Commission’s proposal for the re-processing of single-use medical devices is a sensible one and hope that all the trialogue partners recognise this as they go into negotiations. While the Parliament’s proposal was improved somewhat in their plenary vote, it still allows for devices like syringes and urinary catheters to be reused without imposing on the reprocessor the same obligations as original manufacturers—and that just isn’t safe for patients.
We’re also keen to see a balanced approach on clinical requirements. We’ve noticed an inclination among some stakeholders to simply apply the rules for pharmaceuticals to medical devices. This seems logical on the surface, but in fact drugs and devices are profoundly different (as this cardiologist will tell you at 01:13). The industry is very much in favour of improving clinical data and building on our decades’ long history of carrying out clinical investigations (the device term for clinical trials) for our products. What we want to see is the right trial design for the right product – not a one-size-fits-all approach that we copy and paste from the EU pharma regulation.
It’s hard to argue in favour of keeping so-called ‘’hazardous substances’’ in medical devices, and to be clear, that is not what we want. It’s also hard to justify the immediate removal from the market of countless essential medical devices like blood bags simply because there is not yet a suitable alternative to replace the substances they contain. So instead of banning these substances outright, the medical device industry supports the Commission’s proposal to phase these out gradually and weigh the risk and benefit of each product on case-by-case basis until the phase out is complete.
Systematic scrutiny A reinforced control procedure
Finally, there’s the topic of the Commission’s proposed scrutiny procedure. We’ve spilled many a word on this but lately there’s been some confusion on exactly what industry proposed as an alternative. To reiterate briefly, we find the Commission procedure to be a random, “needle-in-a-haystack” approach –the system should not be “looking for a needle in a haystack” through random checks at the end of a review process but should prevent the “needle landing in the haystack in the first place.”
In our position paper, published in October 2012, we outline the idea of a “systematic control procedure” in which we suggest that the best way to increase patient safety is to ramp up measures to ensure that notified bodies are doing a good and consistent job by making the criteria to become a notified body more stringent and encouraging notified bodies to specialise in certain products.
We’re also keen to make sure that the analysis of clinical evidence for devices is being properly reviewed by clinical experts, who should be publicly disclosed by the Notified Bodies.
Lastly and perhaps most importantly, we want to reinforce government control of the system – to empowering authorities to keep closer tabs on notified bodies and manufacturers through tools like unannounced visits.
At some point though, our “systematic control procedure” became known in MDD circles as “systematic scrutiny,” leading people to believe that industry would support some version of the Commission’s proposed scrutiny procedure.
I want it to be clear that this is not the case. So as of today, I’m renaming our alternative. What industry wants is a “reinforced control procedure.” All of the principles we’ve outlined remain the same.
Same concept, new name.
- Serge Bernasconi, Chief Executive Officer MedTech Europe, EDMA and Eucomed