Elsmar Cove Forum Header Graphic The Elsmar Cove Wiki Sitemap More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar Cove Forums Main Page Elsmar Cove Home Page
NQA-USA
Miner's MSA (Measurement Systems Analysis) Blog 
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > EU Medical Device Regulations
Forum Username

Wooden Line

Official EU Unique Device Identifier (UDI) Requirements

Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
european union regulations and standards, medical devices (general), unique device identification (udi)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 27th January 2014, 07:03 PM
mr.mike

 
 
Total Posts: 92
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.

Sponsored Links
  Post Number #2  
Old 27th January 2014, 10:27 PM
Sam Lazzara's Avatar
Sam Lazzara

 
 
Total Posts: 216
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!
Sponsored Links

  Post Number #3  
Old 29th January 2014, 02:00 PM
mr.mike

 
 
Total Posts: 92
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...
  Post Number #4  
Old 30th January 2014, 04:52 AM
RobertvanBoxtel

 
 
Total Posts: 16
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.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > EU Medical Device Regulations

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
12 Steps to FDA UDI (Unique Device Identification) Compliance (2013) Sam Lazzara Other US Medical Device Regulations 38 12th September 2014 03:50 PM
Unique Device Identifier for Small Dental Screws eileenr ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 3 15th November 2013 02:23 PM
Unique Device Identifier for Software Medical Device ryno fan Other US Medical Device Regulations 3 30th October 2013 06:42 PM
US FDA Unique Device Identification (UDI) Proposed Rule sreenu927 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18 2nd August 2013 12:58 PM
Class II Medical Device Unique Device Identifier (UDI) Requirements Waterman956 US Food and Drug Administration (FDA) 8 20th November 2012 06:08 PM



The time now is 11:28 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".