This report provides an overview of the requirements manufacturers of In Vitro Diagnostic medical devices (IVDs) must meet to sell their devices in the European Union. It includes an update on the ongoing review of the EU regulatory framework for IVDs. The European Commission is expected to release its proposal for a revised framework by mid 2012.
To harmonize different national / Member States requirements applicable to IVDs, EU legislative bodies adopted Directives requiring these products to be CE marked. The CE mark, which represents conformity of a product to the technical requirements described in the Directives applicable to this product, is recognized throughout the EU as a mandatory safety mark. IVDs are regulated in the EU under Directive 98/79/EC, which came into force in December 2003.
What is the CE mark?
CE-marking is the procedure whereby a manufacturer certifies that his product meets the safety, health and environmental requirements of the Directives applicable to its product. CE stands for “conformité europeénne” in French. It is a safety mark, not a quality mark, which is recognized throughout the 27 EU Member States as well as in Norway, Iceland and Liechtenstein.
Who has to comply with the Directive?
The Directive is applicable to manufacturers of IVDs but the obligations of the Directive also apply to “the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name”, including in some instances the distributor.
EU Definition of an In Vitro Diagnostic medical device?
An IVD is defined as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
o Concerning a physiological or pathological state, or
o Concerning a congenital abnormality, or
o To determine the safety and compatibility with potential recipients, or
o To monitor therapeutic measures.”
Examples are blood glucose meters, pregnancy tests, machines which process vials of samples for analysis, dedicated computer printers used for printing of IVD results, and ELISA kits, among others.
In addition to the scope of the Directive, as described above, the manufacturer needs to consider the “intended purpose.” By determining the “intended purpose” of a product, the manufacturer will make it clear whether or not the product should be considered an IVD. For instance a printer used in a laboratory environment for in vitro diagnostic testing will be considered an IT accessory to an IVD, provided the manufacturer specified that its intended purpose is to be used exclusively for printing IVD results for a medical purpose. An accessory to an IVD will be considered an IVD.
Products for general laboratory use are not IVDs. Kits for research purposes only, clearly labeled as such, with no medical or diagnostic purpose, do not need to be CE marked as IVDs.