FAQ

My company already has an assigned SRN, how do I register the devices in Eudamed?
The person submitting the SRN application obtains the LAA profile. To view your profile, simply click on your name on your account home page.
The LAA is the Local Actor Administrator and is responsible for managing the Actor data.
To be able to register devices you must have UDI/Device “Confirmer” profile. By default, after Actor registration, your profile in the UDI/Device section is “Viewer”. To upgrade (…)

Is MEDDEV 2.12/1 rev. 8 still valid for Vigilance procedures?
If not, what are the reference documents?
The MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC (MDD), Directive 90/385/EEC (AIMDD)) and Directive 98/79/EC (IVDD)). It is not aligned with the requirements of the Regulations and is considered. obsolete
You shall update your Vigilance Procedures with the following documents:
– 2024-01-15 MDCG 2024-1 Guidance on the vigilance (…)

Are there any specific items in MDR / IVDR with regards to QMS that you need to know to succeed in the audit that is over and over ISO 13485:2016?
In fact, you need to integrate into your QMS certain processes such as clinical evaluation, risk management, post-market surveillance, and assignment of unique device identification which are not included into the ISO 13485-2016 requirements.
Since most manufacturers have already procedures for these processes, they have to integrated into (…)