The new EU Medical Device Regulation (MDR) 2017/745, which will come into full effect in May 2021, has a major impact on medical device manufacturers worldwide. Implementation of the new regulations has manufacturers facing challenges due to the stricter rules, limited resources, and lack of clear EU guidance. Therefore, we are especially proud to announce that Thirona successfully implemented the requirements and we are now certified against the new MDR.
Thirona's quality assurance officer, Lydia Pannekoek, tells us about the MDR, and what it took to get ready.
Can you tell us in short what the new MDR entails?
The MDR replaces the MDD (Medical Device Directive), which stems from 1993. A lot has changed in the medical device market since then, and those changes are reflected in a new regulation. For example, software as a medical device didn't exist in the MDD and were only regulated by additional standards. But probably the most important change is the stronger emphasis on clinical data. Under the new regulation, manufacturers need to demonstrate that their product is safe for medical use with in-house clinical data; it is no longer possible to rely on 'borrowed' data from other parties.
What changes needed to be implemented to comply to the new MDR?
Thirona already has sufficient clinical data available in-house, as we have always put emphasis on the importance of clinical evaluation and collaboration with clinical experts. Still, we had to improve the way we assess our data. Our methods for clinical evaluation have been refined and are now strongly linked to other processes, such as risk management and post-market surveillance. We have also implemented the necessary general safety performance requirements, such as product label requirements and unique device identification.
What challenges did you come across in the process?
An important but time-consuming first step was to perform a solid gap analysis on our current quality management system and technical documentation. This would make or break the project as it’s the starting point for planning the implementation, including the resources needed. In general, resources in the medical device field are limited, and even experienced regulatory persons need to become familiar with the MDR ‘on-the-go’, while guidance documents are lacking. In terms of implementation, our biggest challenge was the interpretation of the new regulations and how to make this work efficiently in our current system.
Were you worried that Thirona wouldn't be ready in time?
No not really. One of Thirona’s strengths is building relationships and this turned out to be very valuable for becoming MDR compliant. We reached out to our consultant for the topics on which we could use guidance and the communication with our Notified Body went smooth.
Around the time we finalized implementation, the European Commission announced the one-year delay of the MDR. Thus, we could’ve taken longer, but Thirona wanted to avoid regulations slowing down important software developments.
What did you learn from this process?
As quality officer, I actually learned a lot from the whole certification process. Not only about the regulations, but also about our own systems and processes, which will allow me to give our product development team even better support in the future. It has been a tough process, but worth the effort.
What are Thirona’s plans moving forward?
We have passed the first audit, confirming that our quality management system meets all the requirements. The next audit will be more challenging, as it will show whether we have correctly implemented the new procedures in our day to day business. And of course we will be busy with recertification of our updated products as we move forward with software developments. Now that our first product, LungQ, has been certified under the MDR, our other products will follow soon, as new versions and features will be released.