- Notified bodies have yet to issue Medical Device Regulation certificates for more than 85% of the products previously certified under the old directives, according to an industry survey.
- The survey of MedTech Europe members suggests the vast majority of the more than 500,000 devices certified under the old directives have yet to be converted to MDR. The survey indicates that some of the devices likely will never get MDR certificates as 54% of the respondents plan portfolio reductions.
- Notified body capacity may remain an issue despite the withdrawals. MDR certification is taking 13 to 18 months, meaning companies need to start the process soon to meet the May 2024 deadline, and 30% of smaller businesses lack access to MDR-designated notified bodies, the poll found.
A Medical Device Coordination Group’s (MDCG) task force asked MedTech Europe to poll its members to understand notified body capacity. Concerns about capacity persist despite delays to the regulation.
The survey, which covers an estimated 60% to 70% of the market by revenue, quantifies the concerns. As of April, when the survey took place, larger companies were actively filing under MDR but were still waiting on certificates. Notified bodies were reviewing 70% of submitted industry applications. Completion of the active reviews will chip away at the backlog of hundreds of thousands of legacy devices.
However, the MDR certification process is taking twice as long as the old directive pathways and smaller companies are struggling to get started. Seven percent of MDR certificates have been issued to small and medium-sized enterprises (SMEs), compared to 13% on average, the survey found. SMEs will require 40% of the certificates needed by May 2024 but almost one-third of them lack access to an MDR-designated notified body.
Faced with the challenges of MDR certification, some companies are deciding to pull products from the market and half of respondents plan portfolio reductions, the poll said. Those respondents expect to drop one-third of their devices on average.
“Respondents highlighted concerns in every specific product category offered in the survey and added further product areas of particular concern. It is difficult to know which categories of medical device would be left unaffected by MDR implementation. This will have a significant impact on healthcare systems,” MedTech Europe wrote in its summary of the findings.
The survey found evidence that MDCG is hindering the process. One-fifth of respondents reported delays related to new or revised MDCG guidance. Almost half, or 46%, of the delays required rework, it said.