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Official EU Unique Device Identifier (UDI) Requirements

M

mr.mike

#1
Just wondering if the EU has any official requirements in terms of Unique Device Identifiers (UDI)...

The only document I could find was a Commission Recommendations document, 2013/172/EU, dated April 5, 2013.

Has there been any developments since? Are these recommendations due to become "official" at some point? If so, can someone please direct me to the appropriate link...

Thanks.
 
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Sam Lazzara

Trusted Information Resource
#2
Here is what I have learned.
  • European UDI regulation is expected to be a "delegated act" written by the European Commission.
  • Timetable is not clear at this time.
  • In Dec 2014, the International Medical Device Regulators Forum (IMDRF) issued a guidance that is expected to inspire the Commission’s delegated act. You can find it on this page.
  • It seems likely that some EU Member States will move ahead with their own traceability measures sooner.
  • Be on the lookout for national systems that may arise before the European regulatory scheme comes into effect.
 
M

mr.mike

#3
Thanks Sam.
It would be unfortunate if there was to be a bunch of different national systems, though I have a feeling most would have similar requirements (similar to the FDA's 21 CFR 830).

Trouble would be with the database registrations. This could get complicated if there arise a bunch of exclusive databases...
 

RobertvanBoxtel

Involved In Discussions
#4
Also, if you read the commission recommendation, it outlines the expectations about what the UDI needs to build up from. If you already have a (barcoding) system in place / in mind, check the properties of the system against these expectations.
 
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