Commission Decision (EU) 2025/2371 triggered the transition period leading to the 27 November 2026 deadline…
EUDAMED
Taking Our First Steps into the European Market
Discover how Medorah Meditek prepared three Class I medical devices for the European market with Obelis’ support on MDR compliance, technical documentation review, and EUDAMED verification, helping the company move forward with greater confidence.
What Happens on 28 November 2026? The Next EUDAMED Deadline Explained
28 May 2026 was a major milestone for EUDAMED. However, it was not the last important date in the 2026 EUDAMED transition. Following the mandatory use of four EUDAMED modules in May, manufacturers and other economic operators have already entered a new phase of the EUDAMED rollout.
Legacy device in EUDAMED? Here are 4 mistakes that can slow you down
Since 28 May 2026, the EUDAMED UDI/Devices module has been mandatory to use. For applicable legacy devices that continue to be placed on the EU market, the transition period provides until 28 November 2026 to complete their registration in the UDI/Devices module.
From Regulatory Uncertainty to a Successful UK Product Launch
Discover how Obelis Group supported REVE LTD. throughout its UK cosmetics compliance journey, from PIF review and CPSR preparation to SCPN notification, helping the company bring its lipstick to market smoothly, efficiently, and with confidence.
One Product, One Goal, Complete EU Compliance
Discover how Obelis Group supported Sanava AB throughout the complete EU cosmetics compliance process, including laboratory testing, CPSR preparation, PIF review and CPNP notification, helping the company confidently bring its night face cream to the European market.
Supporting a Smooth Path to MDR Compliance in Europe
Obelis Group supported Azista Industries Private Limited with an MDR review and EUDAMED verification, helping ensure continued compliance with EU regulatory requirements. Through expert guidance and practical recommendations, the project strengthened the company’s regulatory framework and supported its ongoing access to the European market.
Strengthening MDR Compliance Through EUDAMED Verification
With Obelis Group’s support, TTK Healthcare Limited successfully completed EUDAMED verification for its Class III heart valve devices, strengthening MDR compliance and supporting its continued growth in the European market.
Entered the Wrong Information in EUDAMED, Now What?
What happens if incorrect information has been entered during device registration and EUDAMED does not allow the information to be corrected directly?
Fortunately, this situation is easier to fix than many manufacturers expect.
How to Approach the Final Days Before the EUDAMED 2026 Deadline in May?
For manufacturers, authorised representatives, and distributors of medical devices and IVDs in the EU, the May deadline represents the moment when full EUDAMED requirements take effect across all relevant modules. With just 60 days remaining, the time for gradual preparation has effectively passed.