Current EUDAMED Timelines:

• The target date for the first mandatory application of functional EUDAMED modules is still January 1, 2026. The Vigilance module is expected to be mandatory beginning in Q3 2026 with full EUDAMED functionality planned for Q2 2027.

• The Actor, UDI & Devices, Certificates, and Market Surveillance modules are currently under audit. The independent Minimum Viable Product (MVP) audit is intended to assess and confirm functionality and interconnectivity of the modules that are deemed audit ready. This audit is foreseen to be completed by Q2 2025.

• Mandatory use of each module is to commence six (6) months after the module is declared fully functional through the independent audit and publication in the Official Journal of the European Union (OJEU). The Actor, UDI & Devices, Certificates, and Market Surveillance modules are expected to be declared fully functional at the end of Q2 2025, leading to their mandatory application date of January 1, 2026.
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• The Actor, UDI & Devices, Certificates, and Market Surveillance modules are expected to be declared fully functional by the end of Q2 2025 and mandatory for industry use on January 1, 2026.

• The Vigilance module is not part of the ongoing MVP audit and will not be declared fully functional along with the previously mentioned modules.  The revised timeline indicates that the audit of that module will occur between Q2 and Q3 of 2025, with the goal of the mandatory application date in Q2 of 2026.
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• The development of the Clinical Investigation/Performance Studies (“CI/PS”) module is intended to continue through Q3 2026.  An audit to assess the CI/PS module together with the other five (5) modules will be completed once the CI/PS MVP has been developed.

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