Self-preservation in the face of regulatory adversity.
Companies operating in some Member States may soon be faced with regulatory burdens going far beyond the requirements of the In Vitro Diagnostic Directive, which will result in greater costs and difficulties in marketing in vitro diagnostic devices. Companies can, however, use rights derived from European Union law to protect themselves from the commercial impact of national rules of this type.
Sheridan
B
B
Oppenheimer Wolff and Donnelly LLP, Brussels, Belgium. bsheridan@oppenheimer.com
D001530:Belgium; D019937:Diagnostic Techniques and Procedures / Q000295:instrumentation; D004867:Equipment Design / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D006801:Humans; D007878:Legislation as Topic; D016365:Liability, Legal