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Notified Bodies Double Certifications Since 2022

 
• By Elizabeth Orr

A recent survey by trade group TEAM-NB found that the number of certificates issued under the IVDR and MDR doubled between 2022 and 2023. However, application completeness remained an issue, with notified bodies estimating that a third of applications were less than 25% complete.

Finger tracing upward line
• Source: Shutterstock

The number of MDR and IVD certificates granted in the EU more than doubled between 2022 and 2023, new data from notified body trade group TEAM-NB shows.

The group’s survey of 35 member notified bodies indicated that respondents issued 4,873 certificates under the Medical Device Regulations (MDRs)...

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