Europe – Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey

  • 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…