25. Juni 2021 How to master the MDR challenge

Successful MDR audit at northh medical

When Kai Fehrs thinks back to the summer of 2020, he is relieved that his business pushed through preparations for an audit in the autumn. The co-founder of northh medical can now look back at the successful Medical Device Regulation (MDR) audit that took place during that season and an EU approval of its novel MRI-compatible ultrasound device in May 2021. “Luckily, we weren’t impacted by the lockdown during the second wave. We were able to continue planning our year as usual,” says Fehrs.

High-resolution imaging of foetal hearts

The start-up, a spin-off company from the Eppendorf University Hospital, was founded in 2017 and is based at the Health Innovation Port on the Philips campus in Hamburg. It has set itself the goal of enhancing diagnostics for congenital heart defects in prenatal testing. “Our device makes high-resolution imaging of foetal hearts available. This has previously not been possible, as current MR imaging cannot be synchronized with the foetus’ heartbeat,” explains Fehrs. Yet, the smart-sync technology does just that – offering gynaecologists, radiologists, and cardiologists the opportunity to better recognize congenital heart defects more in detail and to plan for a customized therapeutic approach. Once, EU MDR approval has been granted in 2021, the ultrasound device may be used in clinical routine. A milestone for the start-up. “We’re delighted that we have left the research stage, and that our product can finally be used in clinics,” says Fehrs. Northh medical joined forces with Reinfeld-based manufacturer Cognimed to turn the initial prototype into a medical product that is production ready. The pilot batch of ten devices is in preparation, five had already been purchased by the end of 2020.

This has also made northh medical one of the few companies in Germany to receive timely approval under the new EU MDR before the official start of the regulation. How did they manage it? “We started on time and sought out quality partners within our network,” summarizes Fehrs the company’s strategy. By 2018, he and his colleagues had talked with notified bodies, consultants and potential partners at MEDICA. Considering the changeover from the MDD to the new MDR, it was already evident at the time that it would be relevant to become a regular customer at a notified body to prevent capacity issues at a later date. “With that in mind, we certified our quality management system a year before we submitted our technical files. In hindsight, this proved to be the right strategy,” enthuses Fehrs. In October 2019, the company’s QM system was certified according to ISO-13485. A year later, the next round of ISO-13485 audit took place and the initial MDR audit for the medical device was conducted as well. This meant a lot of intensive work throughout the summer for him and his team, but their efforts were rewarded.

Clinical evaluation based on literature

One aspect of the process that made things easier for the company was that the clinical evaluation could be done based by existing data from literature. These were gathered over the years through ongoing research collaborations with various renowned centres which were already using prototypes of the device. “The raft of publications we and our partners had under our belt were particularly advantageous here, e.g., with the UKE, the clinic in Lund, Sweden, or with the Boston Children’s Hospital.” These data could be used by NSF Prosystem to perform a clinical evaluation without the company having to do any further clinical studies. “We were fortunate in that we could always discuss these issues here at the HIP, with Philips, and the Life Science Nord Cluster. This resulted in relatively low consulting expenses as we navigated our way through the entire MDR approval process,” concludes Fehrs. On the back of this experience, his business is now on its way to achieving the next milestone: FDA approval of their product and further developing the device so that it can also be used for adults.

System collapse expected for 2023/24

While northh medical can largely put behind it the EU MDR discussions, other medtech experts are looking to the near future with trepidation. The period between 2023 and 2024 will be the most worrying, as May 2021 will no longer mark an important deadline for most manufacturers. Although this is the date when the EU MDR will finally be effective, it is later years that will be decisive, when MDD certificates start to expire. “We are looking forward to a veritable wave of expired MDD certificates, which will cause major issues for all notified bodies in 2023 and 2024,” asserts Klaus-Dieter Ziel, managing director of MEDCERT GmbH in Hamburg. His company is one of the notified bodies that were officially successful in the appointment process for MDR end of 2019. “We didn’t experience much of a rush after our official MDR approval came through in 2019. Less than 5% of our customers turned to us in 2019/2020 with their MDR queries,” says Ziel. These are mainly mid to large-size companies or customers with high-risk medical products. “Many customers whose MDD certificates expired in 2020, or are due to expire in 2021, are either inadequately prepared or not at all prepared,” states Ziel. Instead, the postponement of the MDR by one year to 2021 pushed discussions around MDD re-certifications, early re-certifications or changing certificates.

Yet, these options were not possible forever, as Ziel goes on to emphasize. “We only accepted such applications until August 2020 and then only from our regular customers, as we would have been completely overwhelmed otherwise,” remembers Ziel. Even before the surge in MDD re-certifications and certificate changes, MEDCERT GmbH was fully booked with a very high number of expiring MDD certificates in 2023/2024. Of one thing Ziel is sure: “We already postponed the problems into the future.”

Remote audits have limits

Jan-Michael Krüger who heads up Regulatory Affairs in the EMEA region for Olympus Surgical Technologies Europe in Hamburg is facing a similar challenge. He also fears that they will not be finished with all their products by 2024. “We began in 2017 with a robust plan and are hopeful that we will get through it all by 2024. But if we continue at the current speed and number of employees within the notified bodies, it will be touch and go,” forecasts Krüger. He goes on to underline that “the lack of resources for notified bodies combined with longer lockdowns due to the coronavirus are the main causes of the problem. These are leading to massive delays to scheduled audit activities.” A bit of hope provides the fact, that by 2020, further guidelines were issued to help notified bodies carry out remote audits. Existing customers should benefit from these the most. However, for both the manufacturers and the notified bodies this option still has to be practiced more often and remains a new playing field. And further delays are to be expected.

Complex portfolio planning

Krüger must try to unite such uncertainty with the complex in-house portfolio planning. All products at Olympus are grouped into internal categories which are gradually being converted from MDD to the EU MDR. The category which comes first is not only determined by the risk class, but also the importance of the indication to the company and whether new products are scheduled for that area in the near future. “We want to do more than simply update current products; we also want to ensure that new products can be already certified under the new regulation. But some of our portfolio will disappear with with the end of the transition period to the MDR,” admits Krüger.

To manage the entire process internally with a large volume of products, Olympus also opted for the strategy to conduct first the QM audit in accordance with the requirements of the EU MDR, and only then start scheduling further audits for the different product groups. “We managed to get that QM audit done in February 2020 before the first lockdown, which was a good foundation for our following activities,” says Krüger. He believes that excellent communication with the notified bodies is the most important instrument for a smooth changeover to the EU MDR. Similarly, the expert not only views Europe as a standalone market, as it can also be seen as a guide for many international markets. “We have submitted registration dossiers based on CE mark in around 80–90% of the markets, meaning that after the torrent of EU MDR certifications, we anticipate a wave of international registration dossier updates, too.”

Author: Sandra Wirsching