GIBCO™ in vitro Diagnostic products and the
EU Medical Device Directives
Better cell culture begins with GIBCO™ products and services. As leaders in the Global Market, we pride ourselves on responding to local market requirements including regulatory requirements. Accordingly, effective October 30, 2003, Invitrogen began CE Mark Marking 296 GIBCO™ media, sera, and reagent products that are suitable for in vitro Diagnostic (IVD) applications. We instituted this labelling change in order to proactively comply with the European Union Medical Device directive that became effective for these products in December 2003.
Customers will notice new labels on these products and new documentation accompanying shipments of IVD products. The new label formats incorporate symbols and multiple language product descriptions. The symbols allow universal representation of essential product information and characteristics such as shelf life, storage temperature, biohazard considerations, and the like. To facilitate customer familiarity with the new labels and symbols, a multiple language Label Insert and a multiple language Symbol Glossary is automatically inserted into the shipping documentation with each IVD product order.
It is important to note that the only change to these products is the new label format and label information. There have been no changes to the manufacturing or quality assurance processes for these products. For many years, GIBCO™ products have been manufactured to meet or exceed the requirements to allow us to make an intended use claim of “for in vitro Diagnostic use”. The label changes are necessary only to come into full compliance with the European Union Directive. In a few cases, product catalogue number changes have been necessary. For a complete list of our CE marked products, including a cross reference to those products with new catalogue numbers, please navigate to our GIBCO™ CE Resources page. A copy of the Symbol Glossary and copies of the Certificates of Conformity for products manufactured at our various sites around the world, including media, serum, and reagents, can also be accessed on our resources page.
GIBCO™ products bearing a “CE Mark ” Mark are intended “for in vitro diagnostic use” and the IVD claim is indicated by the symbol IVD Symbol on the label. These products are considered medical devices subject to the requirements of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [Official Journal L 331 of 07.12.1998] and to the requirements of the United States Code of Federal Regulations Title 21, Part 820: Quality Systems Regulation. These products are also suitable for research applications, and in appropriate circumstances, as raw material components in further manufacturing applications. It is the end user’s responsibility to qualify these products for their specific application. These products have not been qualified for, nor are they intended for any animal or human therapeutic uses.
Invitrogen is proud to provide CE Mark labeled GIBCO™ products to our European marketplaces. Our willingness to proactively invest in this capability is one more reason customers turn first to GIBCO™ as the primary manufacturer and supplier of products and services for critical regulatory requirements.