The new EU Medical Device Regulation (MDR) will increase public health and patient safety. It came into force in May 2017 with a transition time of three years for manufacturers of medical devices. The message is clear: you must comply with MDR as of May 25, 2020 in order to manufacture and sell medical devices in Europe. So how does this impact the dental implant industry?
“We are witnessing a historical change,” says Christina Ericson, Vice President Quality
Assurance and Regulatory Compliance at Dentsply Sirona Implants. She points out that MDR will benefit serious actors like Dentsply Sirona Implants and talks about how several scandals rocked the medical device industry some ten years ago. The most infamous one involved a producer of breast implants using industry-grade rather than medical-grade silicone.
MDR is not interpretable—it is the law
The fact that companies cheated, alarmed the European Union. Its Medical Device Directive (MDD) could not keep up with the rapid technological development. The decision was therefore taken to develop MDR. The major difference between a regulation and a directive being that the former is directly applicable and need not be transposed into national law. Something that reduces the risk of different interpretation in individual countries.
Under MDR, the previous focus on solely legal manufacturers shifts to one where the entire value chain is covered, meaning that the levels of responsibility and liability are higher at every tier. This is in line with the demands on traceability and transparency in MDR. Every device must have a Unique Device Identification (UDI). And all serious incidents must be reported to a public database (EUDAMED). This gives all actors on the market access to that data. It also provides patients and health professionals with more and better information.
Notified bodies are key players
MDR makes auditors (notified bodies) more important as it stipulates that independent experts may need to provide their opinions to a notified body before a final decision on certification is made for high-risk products.
Dentsply Sirona Implants certainly has the muscles to perform the job needed, and at the
core of the project we find the project manager, Malin Pfister. “I have worked full time on the project for more than a year. In addition, we have a core team of ten people, but all in all, we involve some 50 employees,” she says.
For a smaller actor, that might not be plausible. Christina Ericson points out another problem for these. Until now, numerous companies have launched medical devices by demonstrating equivalence, which basically is relying on the clinical data of another device. Under MDR that will be more difficult as their notified body will require them to produce their own, high-quality clinical investigations. This might prove tough for minor brands.
The fact that MDR becomes law closes all loopholes. However, this change does not happen overnight on May 25, 2020. There will be a grace period of up to four years. During that period, products certified according to MDD can be placed on the market, unless significantly changed. From 2025, no such devices can however be put into service and must be scrapped.
“If you don’t comply, you are gone,” Christina Ericson says and concludes: “Which is a good thing as there is no room for being careless in our business. To us the Medical Device Regulation is good news just as it is good news for our customers and patients.”
If you want to learn more about MDR, read more here.