A historic day—Dentsply Sirona gets MDR certificate
On May 26, 2021, the European Union Medical Devices Regulation (MDR) went into effect, and Dentsply Sirona Implants is one of the certified actors. In the short run, this allows the company to keep launching products. In the long run, its clinical data may prove to be a critical competitive advantage.
“May 26, 2021, was a historic day. MDR went into effect, and we got the certificate in time—that feels great!” says Christina Ericsson, Vice President Quality Assurance & Regulatory Compliance, Dentsply Sirona Implants. “In short, we can continue launching products and have a license to sell.”
MDR replaces the old MDD (Medical Devices Directive). The most apparent difference between the two is that a regulation is directly applicable in all EU countries and reduces the risk of different interpretations nationally. Also, the requirements for a medical device to be approved under MDR are much more demanding.
A massive and global team effort
The switch from MDD to MDR takes place gradually. In the coming years, Dentsply Sirona’s MDD certificates will become void. The grace period ends in May 2024, and a year after that, any remaining MDD devices must be removed from EU warehouses.
“We estimate that we will need another two years to finish the transition from MDD to MDR,” says Martina Andreasson, Project Manager.
Nearly 20 people work pretty much full time with the project at Dentsply Sirona Implants. In total, some 150 employees make up a cross-functional team that spans seven sites, seven cities in five countries – Mölndal, Sweden; Waltham, US; Kyiv, Ukraine; Bensheim and Hanau, Germany; and Hasselt and Leuven in Belgium. Together their task is to make sure that over 4,000 products can be certified according to MDR. A complex job that includes time-consuming and comprehensive audits from an independent notified body.
Martina continues, “It is clear that working in a cross-functional team is key to a successful result – for example, when Risk Specialists work together with Clinical and Labeling expertise magic things happen and we can assure that a safe product can be delivered to the end customer. This is also a very fun and efficient way of working and project members have done excellent work.”
When in a pandemic—do a quiz
A complicating factor that even delayed the introduction of MDR by one year is the ongoing Covid-19 pandemic.
“Of course, this has affected us as people got furloughed or worked from home. At the same time, we are a global team and already had a clear digital infrastructure in place. I think we got back on track quite quickly,” says Martina.
“What we had to add was ways to motivate people and break their isolation. In practice, this meant shorter, more frequent meetings and a bit of fun as well, like quizzes,” Christina adds.
They both hail the combined efforts of the team as imperative for meeting the first deadline. Maintaining that spirit is vital for the continued process, according to Christina:
“We have acquired a lot of knowledge that will help us move forward with the rest of our products and explore the possibilities of MDR.”
Tougher demands—that’s wonderful news
There is clearly an upside for Dentsply Sirona with this new regulation, Christina believes. For products to be approved, they must undergo a much more rigorous process than before, something that gives Dentsply Sirona clear competitive advantages.
“Clinical data will become even more valuable. MDR dictates that you must have clinical data in order to prove that the product is safe and works as intended, so conducting clinical studies will become important for new product launches. This is good news for a science-driven actor like us who conduct very extensive studies and clinical trials. Furthermore, the importance of post-market studies will increase. All in all, you need to be proactive and handle a lot more data than before. That is a challenge for many, but we can do it. The superb work of our MDR team clearly proves this,” says Christina, and concludes, with pride:
“Reaching the first deadline on time was just the start, but what a great one! Now, we can move on with some exciting product launches while certifying the rest of our existing products according to plan. We really could not ask for a better position than this.”
To learn more about our scientific approach to implant dentistry, go to www.dentsplysirona.com/implants/science
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