The status of EU MDR implementation
Munich-based software company Climedo Health is inviting companies to take part in a new survey on the status of implementation of the Medical Device Regulation (EU MDR 2017/745).
The survey is aimed at medical device manufacturers of all sizes and product classes, but contract research organizations, consultants, distributors and suppliers are also invited to join. The survey will run for approximately 30 days and, upon request, the results will be made available to participants afterwards.
Despite the postponement of the EU MDR deadline by one year, medical device manufacturers continue to face numerous challenges. Last year, Climedo Health conducted two surveys. Among other things, these showed that more than 77% of respondents considered the EU MDR to be "very challenging" and that 48% believed the new regulation would cost their company more than 5% of total annual turnover. At the same time, however, many were still working with relatively manual methods such as paper or Excel spreadsheets for their clinical data capture.
The new survey consists of 18 questions and addresses the following areas:
- Basic company information
- Barriers to EU MDR compliance
- Notified Bodies
- Clinical data capture and Post-Market Surveillance
- A look at the future
"Following the positive response to our previous EU MDR surveys, we are pleased to conduct a further survey among manufacturers and other affected companies just weeks before the new deadline," said Veronika Schweighart, Co-Founder and COO at Climedo Health. "We look forward to evaluating the results and comparing them to last year's data to see where we stand today."
Upon request, survey participants can receive the full evaluation free of charge by email afterwards.