Rubric Publishes Guidelines Offering Assistance to IVD Manufacturers Facing the Fast Approaching Compliance Deadline
Thursday, June 12, 2003
Rubric, a leading localization and translation services provider, has announced the publication of Rubric's IVDD Language Compliance Guidelines. The publication provides an overview of the translation and language requirements resulting from the European In Vitro Diagnostic Medical Device Directive 98/79/EC of 27 October 1998 (IVDD).
With the deadline for compliance fast approaching, manufacturers of in vitro diagnostics (IVD) need to implement strategies immediately in order to reach IVDD compliance by the December 7, 2003 deadline or risk exclusion from the European market. Companies found in noncompliance will face substantial financial and regulatory risks.
Rubric's IVDD Language Compliance Guidelines provides a summary and examination of the translation and language requirements of the IVDD. The publication also touches upon the CE Marking process and explains the relationship between the IVDD and CE Marking process.
Introducing regulatory requirements across the EU for the safety, quality and performance of in vitro diagnostic medical devices, the IVDD was created to establish unified compliance standards throughout the EU. The IVDD should result in streamlined compliance requirements and significant efficiency gains for manufacturers looking to sell to multiple countries within the EU. Rather than wrestle with compliance issues based on each member states' individual requirements and policies, manufacturers will enjoy harmonized requirements across all EU member states.
Acting as a veritable "passport" allowing manufacturers to freely distribute their products in the EU, the CE Mark is a symbol that appears on all products that are in compliance with EU regulations. The IVDD requires CE Marking of IVD products by the December deadline. Any product lacking the CE Mark after the deadline will be blocked from entry into the EU. In effect, no CE Mark, no European market.
About Rubric
Rubric assures a better localization experience. Specializing in globalization services for the high technology industry, Rubric brings flexibility, on-demand scalability, and integrity to guarantee localization success. Rubric's refined processes adapt to the high tech sector's need for proactive localization planning, anticipation of dynamically changing requirements, and agile response capabilities. For more information, visit www.rubric.com.