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european union regulations and standards, medical devices (general), unique device identification (udi)
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  #1  
Old 27th January 2014, 06:03 PM
mr.mike mr.mike is offline
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Question Official EU Unique Device Identifier (UDI) Requirements

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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Old 27th January 2014, 09:27 PM
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Re: Official EU Unique Device Identifier (UDI) Requirements

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.
Thank You to Sam Lazzara for your informative Post and/or Attachment!
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Old 29th January 2014, 01:00 PM
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Re: Official EU Unique Device Identifier (UDI) Requirements

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...
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Old 30th January 2014, 03:52 AM
RobertvanBoxtel RobertvanBoxtel is offline
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Re: Official EU Unique Device Identifier (UDI) Requirements

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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