Remel "ready" for IVDD (In Vitro Diagnostics Directive) deadline with ISO successes
This article was originally published in Clinica
Executive Summary
Remel Europe says it is well on its way to meeting the new CE-marking requirements of the In Vitro Diagnostics Directive (IVDD), after obtaining ISO 9001-2000 accreditation within three months of becoming fully operational, the company announced yesterday (October 8 2003). The standard is a precondition for CE-marking all diagnostic tests under the IVDD, for which the deadline for transposition into national law is December 7 2003.