Animal tissue device rules: can the EU meet its own requirements?
This article was originally published in Clinica
It is almost a year since the publication in the Official Journal of the European Union of the Directive that regulates the management of risks arising from potential TSE-containing components of medical devices. But what of the EU's state of readiness to fully implement the new rules? Thierry Chignon and Phil Brown, of Quintiles Consulting's biological business unit, look at this, at the latest guidance to emerge from the European Commission and at the issues that need resolving before EU industry can expect to be fully compliant.
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