Object of the contractNIBSC supplies materials that are classed as in vitro diagnostic devices (IVDs) under the current European Directive 98/79/EC (known as the IVD Directive). This means that they must fulfil the requirements of the IVD Directive and bear a CE-mark to show such compliance if they are to be sold on the European market. The European Commission has proposed extensive revision to the IVD Directive in the form of a European Regulation (known as the IVD Regulation) that will supersede the current Directive. The current draft of the Regulation was published in September 2012 and outlines (amongst others things) the need for Unique Device Identification (UDIs) of all IVDs. Each IVD will have an associated UDI and will be registered on a European database. This is in order to improve identification and traceability of devices from manufacturer, through the supply chain to the end user. Improved traceability allows for a more effective vigilance and recall system throughout Europe and supports a recommendation from the ‘Medial devices – European Commission calls for immediate actions – tighten controls, increase surveillance, and restore confidence'' 2012 Dalli report. The minimum UDI requirement NIBSC IVDs will need to meet will be a form of carrier (e.g. a barcode) on the label of the vial that when read by an appropriate scanner will allow the software attached to the scanner to access relevant product information such as manufacturer, product name and code, expiry date etc. Final publication of the IVD Regulation is expected in 2015 or early 2016. In order for NIBSC to continue selling IVDs within Europe, they will need to meet the UDI requirements.The UK Department of Health released the NHS e-Procurement Strategy in April 2014, outlining improvements and efficiencies to procurement for the whole of the NHS. This document mandates the use of the global GS1 coding and PEPPOL messaging standards throughout the healthcare sector and supporting supply chains. GS1 coding standard allows unique identification of items with a carrier (e.g. a barcode) that when scanned accesses relevant product information in an inventory management system. NHS have mandated the use of the GS1 carrier 2D Data Matrix (a form of 2 dimensional barcode).The agency will be looking at solutions to fulfill this requirement. The agency will probably be hosting a suppliers day in the future (date to be determined) in order to help it understand the market and to help it develop a specification for a future tender. If you wish to be informed of the suppliers day when it is announced please follow the following instructions: instructions how to express interest register your company on the e-Sourcing portal (this is only required once):1) go to www.phe.bravosolution.co.uk (please note the Medicines and Healthcare Products Regulatory Agency uses the PHE portal);2) click the link to register;3) accept the terms and conditions and click ‘continue'';4) enter your correct business and user details;5) note the username you chose and click ‘Save'' when complete;6) you will shortly receive an email with your unique password (please keep this secure);7) email
[email protected] to confirm you have registered;8) we will then be able to add you to our mailing list to automatically inform you when the suppliers day is announced and the tender is published;9) please note the tender has yet to be published so you will not see it on the portal, the above requirements are to ensure you are on our distribution list and you will receive notification as soon as the requirement is published.
Description: Bar code scanning equipment
Authority Type: National or federal Agency/Office
Contact Nature: Supply contract
Procedure: Not applicable
Document: Prior Information Notice
Regulation: Not specified
Award criteria: Not applicable
CPV code: 35126000, 30199761, 30178000, 38000000, 35126000, 30173000, 30170000
CPV Description: Bar code scanning equipment.
Bar-coded labels.
Semi automatic labelling systems.
Laboratory, optical and precision equipments (excl. glasses).
Label applying machines.
Labelling machines.
Internet address (URL):
Directive: Classical Directive (2004/18/EC)
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