The In-Vitro Diagnostic Directive (IVDD) 98/79/EC covers the essential requirements that an in-vitro diagnostic device must meet before being marketed within the European Union. Document Center now has the recent amendment, 2011/100/EU, which has just been released for the IVDD.
The requirements called out in 98/79/EC are a grouping of requirements covered within the Active Implantable Medical Devices Directive and Medical Devices Directive (MDD) 93/42/EC.
98/79/EC applies to in vitro diagnostic medical devices and their accessories. ‘In vitro diagnostic medical device` means 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.
Because of the way that the Directives are released, all amendments and other changes to Directives first appear as new Directives themselves. So 98/79/EC has been changed a number of times (both corrigenda and amendments). Each change first appears as a separate Directive. With the case of the IVDD, there have also been 2 consolidated editions released, one in 2003 and the other in 2009.
The latest amendment (2011/100/EU) adds “Variant Creutzfeldt-Jakob disease” (vCJD) assays for blood screening, diagnosis and confirmation to List A of Annex II to the IVDD. This provision will be applied after July 1, 2012.
These Directives and many other Medical Device regulations and standards are all available from Document Center Inc.’s webpage, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). One important product that we offer is our updating service, which can be especially important for these types of documents. Ask us for more information.