Munich, March 30, 2020. Munich start-up Climedo Health has published the results of its EU MDR Readiness Survey. The survey was completed shortly before the European Commission’s announcement of the MDR postponement. According to the responses, many MedTech companies were far from ready for the new regulation in many respects.
In light of the current COVID-19 crisis, the deadline for the new medical devices regulation will be postponed by 12 months. According to BVMed experts, expiring certificates, a lack of Notified Bodies and recertification delays due to the Coronavirus crisis were likely to lead to bottlenecks in patient care. On March 25, the European Commission recommended extending the EU MDR implementation deadline.
The goal of Climedo’s MDR survey, which was conducted between February and March 2020, was to evaluate the status of implementation of the new requirements among European MedTech companies. A total of 110 companies from Europe took part in the survey, the majority (86%) from German-speaking countries. Here is an overview of the most important findings:
- More than three quarters (77%)considered the new regulation to be “very challenging
- The main challenges identified were “lack of clarity regarding the new requirements” and “increased resources and costs”
- Around one third believed that EU MDR will cost >5% of their annual turnover
- Only 26% have a fully MDR-compliant QMS (quality management system)
- 34% do not yet have a Notified Body or are currently switching NBs
- Almost half do not (yet) have a PMS plan
- Many companies still use paper (48%) and/or Excel spreadsheets(69%) for clinical data collection (multiple selections possible)
“The announcement of the delay probably comes as a relief to many MedTech companies,” says Veronika Schweighart, Co-Founder and COO of Climedo Health. “Nevertheless, this is not a time for complacency; the coming year will pass quickly and we will face very similar challenges in 2021 as we do today. The survey results show that some have already made good progress in terms of the EU MDR. However, many are still lagging behind, especially when it comes to using cloud-based software for clinical data collection in Post-Market Surveillance activities. Paper-based systems will simply not be able to compete in the EU MDR era. We recommend that manufacturers do not lose any time, but continue planning their implementation, since issues can be addressed independently of the COVID-19 crisis, such as the selection of appropriate software for clinical data collection.
The complete results can be found attached or and can be downloaded here.
About Climedo Health
Climedo has set itself the goal of offering patients the best possible medical treatment through intelligent software solutions. Together with Europe’s leading hospitals, they have developed an innovative cloud-based platform for the clinical validation of medical and pharmaceutical products. By digitally networking all parties involved (manufacturers, CROs, clinics and patients), Climedo enables its clients and users to achieve significant performance improvements, cost efficiencies and thus accelerate the introduction and monitoring of medical innovations on the market.