by In2Pharma | Jun 3, 2026 | News
Europe As previously announced, as of 28 May 2026, the use of key modules of EUDAMED, the European database on medical devices, has become mandatory. The following modules are now in scope: Actors (economic operator registration)UDI/Devices (device...
by In2Pharma | Jan 5, 2026 | News
Europe The European Commission has confirmed the full functionality of the first four modules of EUDAMED, the EU database for medical devices. Starting May 28, 2026, the use of these modules becomes mandatory: Actors: Registration of economic operators.UDI/Devices:...
by In2Pharma | Oct 13, 2025 | News
Europe Following the revision of the Variation Regulation effective as of 1 January 2025, the European Commission (EC) has adopted and published the final version of the guidelines concerning the classification of variations and the operation of the relevant...
by In2Pharma | Sep 18, 2025 | News
Europe The CMDh has published a new version of the cover letter template: CMDh/096/2009, Rev.8 (July 2025).With this update, the eCTD sequence number is no longer included. The use of the latest version is recommended for all new submissions going forward. The updated...
by In2Pharma | Aug 14, 2025 | News
Europe The European Commission has published draft guidelines detailing the revised framework for variations to marketing authorisations of human medicines. These guidelines follow the updated Variation Regulation (EU) 2024/1701, which became applicable on 1 January...
