We are making revisions to our product label statements
We will be updating our product label statements on labeling, packaging, certificates, safety data sheets, collateral, and our website for selected Gibco products. These changes will not impact the form, fit, or function of our Gibco products. The updates are being made to add clarity based on customer feedback and will not impact how you conduct business with us. The information below offers more details concerning these updates and timelines for the upcoming changes.
What is not changing
The product label statement changes do not change:
- Our products (form, fit, and function)
- Our catalog numbers
- Our manufacturing
- Our formulations
- Our legal entities
- Our online product offerings
- Our website functionality
- Your website login
- Your order process
- Your purchase orders
- Your invoices
- Your pricing
- Your packing slips
- Your shipping or delivery times
- Your intended use statements on custom products (except powdered media and selected media products; please refer to the catalog number lists below).
Updates to Ex Vivo Label Statements
Starting in January 2021, the human ex vivo product intended use statement for a subset of our DMEM Gibco catalog products will be removed. The human ex vivo intended use statement will be replaced with, “For In Vitro Diagnostics Use.” This change will align the intended use statements across DMEM media.
For the DMEM catalog numbers impacted by the product label statement changes, see the following catalog number list.
Updates to EU Authorized Representative (EUAR)
In preparation for Brexit and changes to the trading relationship between EU and UK, from Oct 2019, we will be updating our EU Authorized Representative (EUAR) on labelling, packaging, and instructions for use for IVD Medical Devices. These changes are being made only to identify the EUAR for products manufactured in the UK and outside the EU, and will not impact the form, fit, or function of our products or how you conduct business with us.
Starting in October 2019, the IVD the IVD Medical device label will show the EC Rep logo and the EU Representative address in The Netherlands.
Updates to IVD product intended use statement
Starting in March 2019, the IVD product intended use statement for selected Gibco catalog products will be removed. The IVD intended use statement will be replaced with “For Research Use or Further Manufacturing. Not for diagnostic use or direct administration in to humans or animals." Selected custom products will also begin to use this statement in the effective period.
The following will be affected by this change:
- Product labeling
- Certificates of Analysis
- Documentation and literature
- Material Safety Data Sheets
- Marketing materials & advertising
For products impacted by the product label statement changes, see the following catalog number list:
Why are we removing the CE/IVD mark from selected Gibco product labels?
Since most of our customers use these Gibco products in further manufacturing processes or for research purposes, we’re aligning our product labeling to reflect this use. The CE-IVD marked and "For In Vitro Diagnostic Use" (IVD) products will continue to be supplied until current inventories have been depleted. In March 2019, you will start to receive these Gibco products without the CE mark and the IVD statement on the label and other associated documentation. The new product use statement that will appear on these selected Gibco product labeling and associated documentation will be: "For Research Use or Further Manufacturing. Not for diagnostic use or direct administration in to humans or animals." Product is not intended for direct administration into humans or animals. This label change will not affect the product composition or quality standards that we have in place today. All these selected products will continue to be manufactured under our current global quality management systems.
What if I currently use these selected Gibco products in a regulated product or process?
Depending on how your regulated product or process is documented, you may need to amend your specifications and/or registrations. If necessary, please communicate directly with your local competent authority for guidance on what updates are required. Should you need any assistance, please contact email@example.com.
For Research Use Only. Not for use in diagnostic procedures.