Advena Updates Guidance Document Regarding (EU) 2024/1860
Following the publication of the amendment in the Official Journal of the EU, Advena has updated the guidance document that was published last month. The document was updated to make reference to an important date, the date of entry of the amendment, which is stated to be 9th of July 2024. This date is importantas ...
Advena Guidance on UDI Codes
We must agree, the terminology used doesn’t help. Basic UDI-DI, UDI-DI, UDI-PI and UDI all sound very similar and could pave the way for confusion. Put simply, the Basic UDI-DI is primary alphanumeric identifier of a group of devices with the same intended purpose, classification, essential design and manufacturing characteristics, which does not appear on ...
Advena Guidance on Regulation (EU) 2023/607
This amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the limited capacity of the notified bodies. Since its introduction in March, there have been some notable updates that manufacturers should be made aware of. Advena has created a guidance document that will help ...
