EU Issues Brief Technical Update On UDI-DI Code Presentation
There has been a recent update related to how Unique Device Identification (UDI) will be applied to medical devices in the EU. It limits the number of characters that are used in a code and provides a check digit.
You may also be interested in...
While UDI will be required on all products that come under the scope of the EU's medical device regulations, what is the situation for drug/device combinations? The answer is not simple, and depends on an often-tricky regulatory assessment.
The new Eudamed database may be delayed for two years, but the European Commission wants to allow early access to Single Registration Numbers before Eudamed goes live in 2022 to aid voluntary registration in the interim.
How do notified bodies ensure that their personnel, and the teams they allocate for conformity assessment of medical devices, have the precise knowledge and expertise needed? A new EU document gives guidance on this.