EU EUDAMED Readiness for Medical Devices and IVDs: May 2026

EUDAMED readiness is a data-governance exercise as much as a regulatory one. Manufacturers need clear ownership of product, actor, certificate, vigilance, and post-market information so that published data and internal records remain consistent.

What to review

• The source system and accountable owner for each regulatory data element.
• Controls for UDI, device identification, certificate data, and change history.
• The link between vigilance decisions, post-market surveillance, and regulatory reporting.

Practical impact

Preparing a controlled data map reduces the risk of inconsistent information across technical documentation, labels, certificates, and regulatory systems. The same approach supports both medical device and IVD portfolios.

Source to monitor

Check the European Commission EUDAMED portal and implementation updates for current module and timing information.