20. October 2020
Following the information given by the EU-Commission on the new website with Information on the EUDAMED database the first of 6 modules in the EUDAMED system will be available as of 2020-12-01. This will allow the Actors to register themselves prior to the DoA. It will be the first step to generate the Single Registration Number SRN that is required for several documents such as the declaration of conformity etc.. Further the website indicates theta as of December 1st 2020 the EUDAMED website...
20. October 2020
The commission published a new website with information concerning the EUDAMED Database. On the website potential users of the EUDAMED database will find further information concerning: Single Registration Number (SRN) Actor registration request process Documents to provide with the actor registration request User guide for economic Operators Technical documentation (for the EUDAMED database not for devices) The linked documents will give organizations detailed knowledge of what they need to...
30. October 2019
As confirmed by a statement on the Commission's website the MDR portion of the EUDAMED Database will be operational at the same time as the IVDR portion.The statement concerning the state of play is following: The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro...