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Major revisions coming to IVDD

Major revisions coming to IVDDThe European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000.

Since then, the IVDD has provided IVD manufacturers with a single regulation for the European marketplace. Devices marked with the CE mark can be introduced into 32 European countries (European Union member states, European Free Trade Association countries, and Switzerland and Turkey).

Earlier this year, European Union regulators' public consultation on proposed revision resulted in strong support for adopting a risk-based classification for in vitro diagnostic devices from stakeholders.

IVD Technology published a good overview of the proposed Revision of Europe's IVD Directive 98/79/EC. The EC's summary of responses to the public consultation is also available for download [PDF link].

Medical translation professionals take note: While there is still a long way to go between now and the actual implementation of a revised IVDD (a draft is planned for early 2012), implementation probably will happen by 2015.

ForeignExchange Translations provides specialized software localization and regulatory translation services to medical device and IVD companies. Contact us to learn more.


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