European Animal Tissue Directive.
In less than nine months, manufacturers of medical devices containing certain types of tissues of animal origin will need to ensure that their products comply with newly mandated specifications. They should not wait until the last minute to begin this work. This article discusses the important issues that will need to be addressed to ensure effective compliance with the requirements.
Donawa
Maria
M
donawa@srd.it www.donawa.com
D000818:Animals; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004282:Documentation; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D019983:Guideline Adherence; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D019736:Prostheses and Implants / Q000592:standards; D018570:Risk Assessment / Q000331:legislation & jurisprudence* / Q000592:standards*; D023822:Tissue Engineering / Q000331:legislation & jurisprudence* / Q000592:standards*