Interview on the MDR certification of the corpuls3/corpuls3T
We have received EU MDR certification for our corpuls3 and corpuls3T defibrillators. Meaning the devices, which can be divided into three modules, meet the much more stringent requirements of the MDR (Medical Device Regulation (EU)2017/745).
In the following interview with Dr. Lukas von Stülpnagel (Senior Vice President Innovation & Technology) you can read what this certification means for our customers and users as well as for us as a company. You will also find out more about why we now have a future-proof, MDR-certified telemedicine solution in our product range.
1. What’s behind the EU Medical Device Regulation (MDR) and why is it now much harder to meet the requirements?
Dr. Lukas von Stülpnagel: The MDR is intended to ensure even higher safety, quality and transparency for medical devices in the European Union and it is mandatory for us manufacturers. The regulation replaces the MDD and has been legally binding since May 2017. Since then, the safety and quality requirements have increased significantly; they are a lot more extensive and more clinical evidence is required. Risk classes have also increased in some cases: the corpuls3/3T and all other defibrillators with AED function are now classified in the highest risk class (Class III). The transition period runs until December 31st, 2027. This is because not only new products, but also all existing products must be certified according to the new requirements.
2. To what extent is the MDR certification a significant validation for corpuls?
Dr. Lukas von Stülpnagel: Both the corpuls3 and corpuls3T have been very successful in the market for many years. This certification validates conformity to the very high requirements of the MDR, and the high quality and safety of the devices insofar as they now also meet the significantly more stringent requirements for “Class III” products. Our teams see this as an incentive to keep developing our already high quality standards.
3. Will the certification change anything tangible for corpuls?
Dr. Lukas von Stülpnagel: Yes! We are now able to make innovative changes to the MDR products again. This was not possible during the transition phase from MDD to MDR.
4. What advantages will our customers and patients gain from the certification?
Dr. Lukas von Stülpnagel: The MDR sets very high standards for the quality and safety of medical products. Customers and users therefore receive confirmation that they can trust our products and our equipment. Those who choose our devices are set for the future and do not have to worry that they may not be able to use them in a few years’ time. And of course, the patients themselves benefit from it. After all, the MDR is above all about increasing patient safety.
5. What makes us a leading provider of a future-proof, MDR-certified telemedicine solution due to the certification of the corpuls3/corpuls3T?
Dr. Lukas von Stülpnagel: Unsere Telemedizin-Software corpuls.mission LIVE hatte – genauso wie unser Thoraxkompressionsgerät corpuls cpr – schon die MDR-Hürden genommen. Da nun also sowohl corpuls.mission LIVE als auch der corpuls3 MDR-zertifiziert sind, stärken wir automatisch auch unsere Telemedizinplattform corpuls.mission.Our telemedicine software corpuls.mission LIVE – just like our thorax compression device corpuls cpr – had already overcome the MDR hurdle. Now that both corpuls.mission LIVE and the corpuls3 are MDR-certified, we have automatically strengthened our telemedicine platform corpuls.mission.
6. We now have the MDR certificates for the corpuls3/corpuls3T, the corpuls cpr and corpuls.mission LIVE. What about our other products?
Dr. Lukas von Stülpnagel: All our other corpuls products are currently undergoing the MDR conversion. Our teams are working hard to ensure that the other devices receive certification as quickly as possible. We are convinced that with our standards and our excellent quality management, this will be a success.
You can find more information about our modular patient monitor/defibrillator corpuls3T here.