title: Regulatory challenges for diagnostic development - a European perspective.
abstract: This editorial outlines the regulatory challenges manufacturers face in the form of changes to the regulatory system for in vitro diagnostic (IVD) medical devices over the next 2 - 4 years. Possession of timely and pertinent information is important for IVD medical device manufacturers to enable good decision making in the design and manufacturing process for IVD medical devices. Highlights are given of changes and issues related to regulatory issues including legislation and related documents and standards. As well as a review of possible changes to the main legislation on IVD medical devices Directive 98/79/EC, reference is made to legislation on chemicals, hazardous substance, animal by-products and hazard labelling. Access to good information sources is important, as well as the ability to judge the significance and likely speed of any changes.
authors.affiliation: Director Regulatory Affairs, European Diagnostic Manufactures Association, Place des Maïeurs 2, B-1150 Brussels, Belgium +32 2 777 0274 ; +32 2 772 2329 ; k.howes@edma-ivd.be.
authors.forename: Karen
authors.initials: K
authors.lastname: Howes