Survey: One Year after the EU MDR Delay – Lack of Clarity, Manual Processes and High Costs for Manufacturers Persist

Survey: One Year after the EU MDR Delay – Lack of Clarity, Manual Processes and High Costs for Manufacturers Persist

DATE

April 15, 2021

Munich, Thursday, April 15, 2021 – Munich-based software company Climedo Health has published the new survey results on the status of EU MDR implementation. 

 

The aim of the MDR survey, which was conducted between March and April 2021, was to analyze the status of EU MDR readiness among companies one year after the regulation’s postponement and a few weeks before the new validity date. 115 companies from all over Europe took part in the survey, 74% of them from German-speaking countries and 81% medical device manufacturers. All risk classes were represented. Some of the results in the analysis have been compared to last year’s results and some new questions have also been added.

 

Here is an overview of the key findings:

 

Barriers to MDR compliance and cost burden.

 

Shift in EU MDR and status of Notified Bodies.

 

Clinical data capture

 

A look at the future

 

“The survey results show that the EU MDR continues to be very challenging, expensive and time-consuming for companies,” says Veronika Schweighart, Co-Founder and COO at Climedo Health. “In particular, manufacturers of lower classified devices feel that the requirements are not proportionate to their risk class. In addition, few companies seem to have gained much clarity in the past year. We found it particularly interesting that ‘time’ is perceived as the greatest challenge in clinical data capture, yet many companies still work with paper and/or Excel sheets, which they in turn see as not very time saving at all. With Climedo’s digital solutions, we’ve been able to help clients in overcoming many MDR-related and administrative burdens, and we see tremendous potential in digitalization for manufacturers of all classes.”

 

The full survey results are available for download here.