How can you turn the Medical Device Regulation (MDR) into a competitive advantage? To find out, we talked to the duo heading Dentsply Sirona Implants MDR team.
MDR marks a historical change for the med tech industry, according to Christina Ericson, Vice President Quality Assurance and Regulatory Compliance, and Malin Pfister, Project Manager MDR. Malin has worked full time on the project for more than a year and offers a very straightforward advice to all concerned: “Start in time and make sure to get the internal team onboard.” Talking to Christina and Malin reveals a transition that is complex yet manageable if done right. Here is a quick rundown of how a smooth MDR transition can look like, based on their top five priorities.
1. Identify the gaps—and close them
First of all, you need to perform a gap analysis of your operations. This reveals the scope of the work and helps you discover possible pitfalls. It shows whether your systems, processes and documentation meet the MDR requirements or need changing. With this as a base, you can decide on actions, determine what procedures to update or create and generate a road map for the entire MDR project.
2. This is a big job—eat the elephant one bite at a time
MDR came into force in 2017. When the transition period ends in May 2020, manufacturers must comply with the regulations. Having said that, previously certified devices, unless significantly changed, can still be put on the market during a grace period of up to four years. In other words, a lot of the work takes place after May 2020. Therefore, make sure to eat the elephant one bite at a time and run smaller projects with defined aims, responsibilities and deadlines. This delivers benefits all along the way. It also helps you perform tasks in the right order, starting with the ones that must be finished in May 2020.
3. Find the right notified body
While the conformity assessment is the base, this is sometimes followed by a scrutiny process/consultation where a notified body write a clinical assessment report of the medical device and send it to an expert panel. The panel decides if a scientific assessment report is needed. If so, this must be provided to the notified body within 60 days to be considered within the conformity assessment. If it is not needed, the notified body finishes its report. Given that MDR concerns all types of medical devices, notified bodies are in high demand. It may take time to find one that is designated under MDR, so act now. However, do not act in haste. List your demands to ensure that the notified body of your choice has the necessary expertise.
4. Get the technical documentation right
The demands on the technical documentation have increased too. It represents the entirety of the documents describing a device. As an example, Annex II of MDR details more than forty specific elements for the content of the documentation. In addition, another fifteen mandatory elements concerning post-market surveillance appears in Annex III. Put simply, this documentation is more comprehensive than before and must be approved in order for devices to comply with MDR.
5. Keep building the team
MDR transition requires long-term input and help from the entire company. One example is the before-mentioned documentation. This is approved in a certain sequence, which calls for consistent, seamless and cross-functional cooperation for the entire duration of the project. To ensure this and maintain good team-spirit, you need to continuously inform, inspire and educate your colleagues. Keep them in the loop—you are in this together.
From talking to Christina Ericson and Malin Pfister, it is evident that they trust the process and the team at Dentsply Sirona Implants. While characterizing the job as both tough and fun, Christina Ericson points to its upsides as we conclude our talk: “Done right, this may help increase the speed to market and give us a competitive edge. If you ask me, we are ready for this.”
Read more about how MDR will be a historical change for the dental implant industry.