Implementing new European vigilance procedures.
The new European vigilance guidelines come into force on 1 January 2008. In addition, the Directive amending the medical devices Directives, which includes some aspects of the vigilance system, was recently published. This article discusses the amendments concerning vigilance requirements, the new European vigilance guidelines and steps that manufacturers should take now to prepare for these.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union / Q000458:organization & administration*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence / Q000592:standards*; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence* / Q000592:standards*