The effects of the COVID-19 pandemic are causing great uncertainty in the MedTech sector. The one-year postponement of the EU MDR offers manufacturers a little buffer to better prepare for the regulation and a chance to catch their breath. Nevertheless, experts recommend not wasting any time here and to continue planning as much as possible in order to avoid a huge backlog of work which could have devastating effects on manufacturers. Many areas can be tackled independently of the crisis, as we demonstrated in this week’s webinar.
In order to present the current status of the EU MDR as well as our survey results and some best practices, our EU MDR Pulse Check, which included live surveys and a discussion, took place on Tuesday, May 26, 2020 – the day when the EU MDR was originally meant to come into force. We were very pleased to welcome about 50 participants to our 45-minute session.
Following an introduction by our Account Manager Jan Brützel, who also moderated the webinar, our Marketing Manager Catherine Higginson gave a short overview of the EU MDR state of affairs and explained some of the reasons for the recent postponement. Among the main reasons were of course first of all the COVID-19 pandemic and the possible product shortages that could have resulted if certain products hadn’t been re-certified under MDR on time. Furthermore, there are still too few Notified Bodies; last week the 14th (Intertek from Sweden) was certified under MDR, even though the EU had promised to have 20 by the end of 2019. She then presented the most important results of our EU MDR survey from the spring which had 110 participants from the MedTech sector. Some of the questions were also presented to the webinar participants in a live poll to see if anything had changed since the postponement.
According to the EU-MDR survey conducted in spring, 77% of respondents felt that EU-MDR was “very challenging”. The live survey with the webinar participants reflected this statement despite the recently announced postponement: Again, the large part of attendees considered the new regulation to be very challenging and on a scale of 1-10, chose the number 8 (1 = not challenging at all; 10 = extremely challenging). According to the MDR survey, the “lack of clarity among the requirements” (73%) and an “increased cost/resource burden” (72%) were among the greatest challenges. Interestingly, the lack of Notified Bodies were less of a challenge according to the survey conducted back in spring.
When asked about the systems used for clinical data collection, the live survey confirmed that the webinar participants were a little more digitalized than the survey participants at the time. In the spring, 33% said they were using an EDC (Electronic Data Capture) system, in the webinar it was already 45%, which is encouraging. Nevertheless, the majority of participants still use analog methods for clinical data collection, such as paper or Excel sheets.
Afterwards, our COO and co-founder Veronika Schweighart demonstrated recommendations on how to proceed after the postponement, as well as practical tips on the use of digital solutions for PMS and PMCF. In a 4-point plan she recommended that medical device manufacturers start with a rough planning now and use the time to already create a data basis.
In addition, Veronika emphasized that early cooperation with users and a meeting at eye level is very important for a good cooperation in the future and should therefore definitely be started now. She emphasized that an investment in digital tools is definitely worthwhile, as they can create a competitive advantage. At the same time, users, such as doctors, can be encouraged to provide feedback through flexible surveys. This can be done, for example, by scanning a QR code that links the user to a mobile survey that can be conveniently filled out on the smartphone.
In a live survey, Veronika also asked how strongly the participants were in touch with the users of her product. Most of the participants (40%) stated that they were in regular, personal contact with sales representatives. However, 30% confirmed that they only had rare or sporadic contact with their users and 15% did not have any contact at all.
During the discussion round, both the panellists and the external participants shared their experiences on the postponement of the EU MDR and the preparation for the upcoming legislation and many different opinions were visible.
We were very pleased about the great interest in our webinar and thank you for the large number of attendees and the exciting discussion! The feedback we have received so far has been consistently positive as well. Here’s a little excerpt:
“The webinar was very professionally conducted, short, informative and without extensive digressions. This is certainly an advantage over conventional webinars. The questions and the prompt evaluations were very good. “ – Feedback by webinar attendee
You can find the full webinar slide deck (in German) here: