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One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain

Article-One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain

Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement and a few weeks before the new validity date.

Medtech’s countdown to the European Union’s Medical Device Regulation (EU MDR) was reset when the EU Commission, Council, and Parliament delayed the regulation’s application to May 2021. Yet, as the new validity date approaches, manufacturers continue to note challenges with the EU MDR such as a lack of clarity, high costs, and time-consuming processes. 

Munich-based software company Climedo Health has published new survey results on the status of EU MDR implementation. The survey was conducted between March and April 2021 with the aim of analyzing the status of EU MDR readiness among companies. Climedo reported that 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 results from the firm's 2020 survey and some new questions have also been added, Climedo noted. Below is an overview of the key findings.

Barriers to EU MDR compliance and cost burden.

  • 81% consider the EU MDR to be "very challenging" (up from 77% in 2020)
  • The top challenges still include "increased resources and costs" (70%), "lack of clarity" (59%), and "required clinical investigations" (54%) 
  • 31% estimate that MDR will cause additional costs of between 5% and 10% of their annual revenue; 13% even believe it will be more than 10%

Shift in EU MDR and status of Notified Bodies.

  • For 43%, the MDR delay has not made their daily work easier
  • 72% now have an MDR-certified notified body (up from 52% in 2020); for nearly 40% of these participants, finding a notified body was "not at all challenging"
  • 61% have made use of virtual audits or plan to do so

Clinical data capture

  • 46% still use paper for their clinical data capture; 61% use Excel; however, more than half of all survey participants see "no benefits at all” in these relatively manual solutions
  • The main challenges in clinical data capture include "time required" (61%), "lack of personnel" (33%), and "high costs" (32%)
  • 50% need to conduct post-market clinical follow-up activities

A look at the future

  • "Traceability" (43%) and "transparency" (40%) were cited as the greatest perceived benefits of the EU MDR; however, 32% saw "no benefits at all"
  • 75% would like to see "clear guidelines" from the EU Commission, 50% would like to see more "professional support," and 39% would like to see more "training or informative events"

"The survey results show that the EU MDR continues to be very challenging, expensive and time-consuming for companies," said Veronika Schweighart, co-founder and chief operating officer 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

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