Dive Brief:

• Members of Europe's medtech industry reported in a recent survey that the EU's Medical Device Regulation is challenging and costly, with three-fourths of respondents wanting clearer guidelines from the European Commission. The survey of 115 participants across Europe was conducted by the Munich-based software company Climedo Health.
• Eighty-one percent of respondents said that the MDR was very challenging, up from 77% in a similar survey that was conducted by Climedo in 2020. The majority of respondents cited their greatest challenges as increased resources/costs, lack of clarity and required clinical investigations.
• Despite the concerns raised by the companies, 57% of respondents said the postponement of the MDR made life easier and 72% indicated that they already have an MDR-certified notified body.

Dive Insight:

The survey comes nearly one year after the delayed implementation of the MDR as Europe and industry were dealing with the challenges of the coronavirus pandemic. Even with the delay, concerns abound over the effects the pandemic is causing as the implementation deadline approaches, such as the lack of in-person audits and countries' differing opinions around virtual audits.

The MDR is now scheduled to take effect May 26.

Seventy percent of respondents to the survey said increased resources/costs was their greatest challenge, with 44% of respondents indicating the MDR will cost them 1%-5% of annual revenue. Some respondents are concerned that costs could be even higher as 31% of companies said the MDR will cost them 5%-10% of annual revenue and 13% said costs will be over 10%.

Having to invest extra time during the week to meet requirements was also a top concern, with 64% of respondents saying that meeting new MDR requirements takes them more than five additional hours per week.

The survey was conducted between mid-March and mid-April, 81% of the 115 company respondents were categorized as medical device manufacturers.

While an overall lack of clarity regarding the new regulations was one of the greatest challenges for 59% of respondents, this concern among companies has dropped in the last year. In a 2020 survey, 73% of respondents said lack of clarity was one of their greatest challenges.

Some trends seem to be going in the right direction. The number of respondents saying they now have an MDR-certified notified body has increased by 20 percentage points since 2020 to 72%.

Similar concerns with the overall MDR requirements — additional time, higher costs and lack of personnel — were reported specifically regarding clinical data capture. The majority of respondents, 61%, said time required was the biggest issue with clinical data capturing.

Looking forward, respondents identified traceability and transparency as the greatest benefits of the new MDR requirements. However, 32% of respondents said that there will be no improvements.

The majority of respondents want clearer guidelines from the EC, and half said professional support is needed from the commission.