Timelines And Deadlines For Stakeholders To Submit Information To EU’s Eudamed Database

IT system deadlines are renowned for being delayed. With speculation that the full implementation of the Eudamed medical device database will be postponed again, what will this mean for stakeholders?

Businessman examines a tablet with a magnifying glass.

The timelines and deadlines for uploading information into the upgraded Eudamed database have never been easy to understand. Indeed, the complex wording and cross-referencing in Articles 123 and 113 of the Medical Device Regulation and IVD Regulation, respectively, have perplexed even the experts and lawyers over the years.

Gradually, light has been shone on Eudamed’s intricate web of compliance conditions, and the Medical Device Coordination Group has issued guidance

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from In Vitro Diagnostics

Guardant Health Launches Germline Hereditary Cancer Test

 

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By 

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

More from Diagnostics

23andMe Purchase Will Let Regeneron Scale Drug Development

 

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By 

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By 

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.