UDI goesEUROPE EmblemDMTRX140206vkl50

Date: 20 June 2018, 13:00-17:00 with and at the IHK-Darmstadt
UDI symposium, June 20, 2018, IHK-Darmstadt

Unique Device Identification (UDI) in Europe and worldwide (+Emblem: UDI goes Europe)
Practical information on successful implementation for manufacturers
Program info here

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The European Commission and the manufacturers associations "Medtech Europe" and "COCIR" held their first international UDI workshop of 2018 at 12th of February just prior to the kick-off to the new work item "UDI Application Guide" of the International Medical Device Regulatory Forum (IMDRF).

The subject UDI (world-wide medical device and in-vitro diagnostica system to support tracking and tracing) was initiated by regulators, industries, coding agencies and hospitals. The many contributions from Asia, Europe and Nort/South Europe are allowing an universal overview of the world wide harmonization efforts.

Please feel free to click on the Report written by Heinrich Oehlmann:

pdfReport "International Workshop on global use and application of UDI"

At the UDI workshop HIBC has been invited for a presentation as one of the coding agencies recommended by IMDRF (GS1, HIBC, ICCBBA). Harald Oehlmann presented the world-wide view of HIBC. Please feel free to download his presentation:

pdfPresentation charts Harald Oehlmann: The role and tasks of the issuing entity HIBC

We want to express our thanks to all active persons making the 30 year old dream becoming true, that errors can be avoided by a common Barcode&Data concept for medical devices, for logistics, application and documentation effective for all over the world.

held their first international UDI workshop of 2018 at 12th of February just prior to the

udilookup 32x32HIBIScan 8.4 is released and features the following changes:

 

  • Bug fixed that every date starting with a 0 and containing a 8 or 9 is errorneously shown as errorneous
  • labelers.csv was highly updated.

HIBIScan may be downloaded in the member area.

Publication of Regulation MDR and IVDR Official Journal of the European Union L117, 5 May 2017 fekdlojoehaaahhg

<click hier >

UDI book "Unique Device Identification", published in German language by DIN-Beuth-Verlag.

<Link zum Buch>

buch

udilookup 32x32HIBIScan 7.1 may query the US UDI Data Base and displays any found master data.

HIBIScan may be downloaded from the member login at http://www.elmicron.de/login.

udilookup 32x32HIBIScan 8.0 supports HIBC in revision 2.6 containing an optional quantity field at the end of the code with FDA conformity.

HIBIScan may be downloaded at Elmicron under: http://www.elmicron.de/index.php?option=com_visforms&view=visforms&id=3&Itemid=546.

udilookup 32x32Using HIBIScan 8.2, a Datamatrix code symbol may be created and saved.

 

News in this version:

  • code resolution may be chosen in the options menu.
  • code symbol may be copied to clipboard for easy usage in a graphic program

HIBIScan may be downloaded at Elmicron under: https://elmicron.de/download/hibiscan.html.

hibiscan 32x32HIBIScan 6.4 additionaly supports extended HIBC codes with a quantity and a serial number field. This is provided by the current HIBC provider standard revision 2.5.

Those codes feature a secondary code part like "/$$812/SSER123" or "/$$912345/SSER123".

The download is available at http://www.elmicron.de/

HIBIScan allows to check and generate HIBC codes. The included batch wizard allows to create a set of codes in one run.

Next step of the UDI-registration wave: Beginning February 1, 2016, FDA will accept GUDID account requests from labelers of US class II devices. Manufacturers will be in the position to register this class of products after the personal account has been set up by FDA and acknowledged. The first step was to open the registration for class III devices.

HIBC UDI Emblem DMTRX 140206b

150505-LS kleinUDI presentation from Laurent Selles, European Commission DG for Internal Market, Industry, Entrepreneurship and SMEs Unit D4 – Health Technology & Cosmetics available as video.  >> click here