When does MDR legislation go into effect? Because the law that monitors the safety of medical products places a lot of demands on both producers and certification bodies, there’s no easy answer to that question. Latest reports even indicate that it might not go into full effect until after 2028. Together with ECM, however, we will be ready before then. Twan Wackers tells us how.
Twan is our Medical & Regulatory Affairs Manager, and he is guiding ECM through the MDR certification. The MDR, or Medical Device Regulation, is a European regulation that will replace the current MDD (Medical Device Directive). Twan explains the reason for this: “The MDD is a directive, or guideline. Some parties have unfortunately taken advantage of its less stringent nature, so the EU has introduced the Medical Device Regulation.”
MDR brings big changes
One of the most famous examples of the abuse of this directive is the PIP scandal, involving a French company that used industrial silicone for breast implants, instead of medical-grade silicone. For many women, the consequences were catastrophic. Like the Softenon scandal for pharmaceuticals, PIP is a painful example of the gaps in the original legislation. The introduction of the MDR should change all that.
Enhanced patient safety
“The MDR guarantees improved safety for patients”, explains Twan. “This is mainly because medical product manufacturers and suppliers must prove that their products are safe and effective in much greater detail. One way to compare the two is that with the MDD we had two boxes full of binders containing documentation; with the MDR, we’ll have three pallets. And that too will have some consequences; not just for a lot of companies, but also for the notified bodies, which are responsible for checking whether companies are complying with the law.”
Dramatic reduction
To make matters even more complicated, the strict and comprehensive MDR legislation has caused the number of notified bodies in the European Union to diminish from around 1,000 to less than 100. “And on top of that, the national governments will be keeping an eye on them too”, says Twan. “In short: we face an enormous challenge. It’s so big, in fact, that not everyone will be willing to take it on. Some companies are already saying: ‘If that’s how it’s going to be, then we’ll just stop what we’re doing’.”
we’ll be ready in time’’
Acceleration?
At ECM, we aren’t afraid of a challenge. We have over 1000 different tubing sets in our product portfolio which all need to be MDR-certified. But Twan sees opportunities to accelerate that process. “We manufacture our tubing sets entirely to the specifications of our clients, who are mainly perfusionists. That means they’re all customized. However, they all serve the same basic goal: connecting the patient to the machine that takes over blood circulation when the heart is stopped during open-heart surgery.”
Extra tests and proof
Unfortunately, our notified body has doubts about our claim that they will be able to evaluate our tubing sets all at once. “So extra tests need to be executed”, says Twan. “We’ve been working on that for a couple of years now.” We will reach an important milestone this year: The ECM registration team and Twan expect to have all of the documentation in order by the fall of 2024. “Then we’ll undergo evaluation by the notified body. If everything goes according to plan, the evaluation of the documentation should be complete within a year or so. And after we get approval, we can start working under our new certification.”
Ready for the future
Incidentally, that won’t mean that the law can be fully enforced even then, because the date for full implementation (originally 2024) has been postponed until 2028. “And then we’ll have to see whether the medical companies are ready by then”, Twan cautions. “But together with ECM, we believe that we’ll be ready in time.”
Perfect moment
For Twan Wackers, the MDR challenge appeared at the perfect moment. After a 40-year career in medicine (25 years in the medical device sector and 15 years in the pharmaceutical industry), he still wasn’t ready for retirement. “When this opportunity at Vetico and ECM came up, I seized it with both hands. MDR certification is a complex issue, but I’m looking beyond that. How great would it be for us to have our files in order, and to continue to contribute to patients’ well-being? This is also a crucial phase for ECM, by the way. That’s why it’s so important that Vetico stands behind this investment, because it will enable us to build directly on ECM’s future.”
