New Survey on the Status of EU MDR Implementation in MedTech Companies

New Survey on the Status of EU MDR Implementation in MedTech Companies

March 10, 2021

Where do manufacturers stand one year after the postponement?

 

Munich, Wednesday, March 10, 2021. 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 around 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 three-quarters (77 percent) of respondents considered the EU MDR to be “very challenging” and that nearly half (48 percent) believed the new regulation would cost their company more than five percent 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 20 questions, takes three to five minutes to complete, and addresses the following areas:

  • Basic company information
  • Obstacles to EU MDR compliance
  • Notified Bodies
  • Clinical data capture and Post-Market Surveillance
  • Looking ahead 

 

“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. 

 

The survey can now be accessed here.

 

About Climedo Health

 

Climedo Health’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products.

 

By digitally connecting all stakeholders (medical device manufacturers, pharma companies, CROs, hospitals and patients), Climedo Health allows for increased performance, better cost-efficiencies – and ultimately – accelerated medical innovation.