Software company Climedo Health has announced the results of its EU Medical Device Regulation (MDR) Readiness Survey.
The company conducted the survey shortly before the European Commission announced EU MDR would be postponed. However, this delay will likely be welcomed by organisations, as according to the survey responses, many medtech companies were far from ready for the new regulation in several respects.
As a result of the COVID-19 pandemic, the deadline for the new MDR will most likely be postponed by 12 months. Reasons for the delay according to Germany's BVMed experts, includes expiring certificates, a lack of notified bodies, and recertification delays due to the coronavirus crisis which is expected to lead to bottlenecks in patient care.
The goal of Climedo’s EU MDR Readiness 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, with the majority of participants (86%) from German-speaking countries.
Some of the key findings included:
- 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 more than 5% of their annual turnover.
- Only 26% had a fully MDR-compliant QMS.
- 34% did not yet have a notified body or were currently switching notified bodies.
- Almost half did not (yet) have a PMS plan.
- Many companies still used paper (48%) and/or Excel spreadsheets (69%) for clinical data collection (multiple selections possible).
Veronika Schweighart, co-founder and COO of Climedo Health commented: "The announcement of the planned EU MDR delay probably comes as a relief to many medtech companies.
"Nevertheless, this is not a time for complacency. The coming year will pass quickly, and we will find ourselves facing very similar challenges again in 2021.
“The survey results show that some have already made good progress in terms of the EU MDR implementation. 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 many issues can be addressed independently of the COVID-19 crisis, such as the selection of a web-based solution for clinical data capture."
You can view the survey results in full here.