IVD Directive definition

IVD Directive means Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as it may be amended from time to time.
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IVD Directive means the In Vitro Diagnostic Directive 98-79-EC and any amendments thereto governing in vitro diagnostic devices in the European Union.
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IVD Directive means European Parliament and Council Directive 98/79/EC on ‘In Vitro Diagnostic Medical Devices’ and comparable directives issued by the United States Food and Drug Administration.
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Examples of IVD Directive in a sentence

  • All regulatory matters regarding obtaining and maintaining any necessary clearance or other permit, permission, consent or approval, or promotion or labeling, or otherwise complying or assuring compliance with applicable law for or relating to the importation, sale and use of Celera Products, if any such requirements exist, from the FDA, or under the European IVD Directive or any other body or agency, will remain under the exclusive control of Celera and will be solely Celera’s responsibility.

  • Supplier and Supplier’s Affiliates shall maintain reproducible records of all such technical information and shall make such information available to RDR and RDO within 48 hours of its requests to assure compliance with the European IVD Directive.

  • For the Product(s) supplied under this Agreement, Supplier shall maintain comprehensive technical documentation (including complete production process documents and testing documentation and a listing of associated operating procedures and drawings for the manufacture of the Product(s) to support the Product(s) submission for IVDD compliance) as required by the European IVD Directive.

  • If the Purchaser/User intends to compare it to a test with the CE mark, Zalgen must be notified in writing for review and approval, and to obtain the appropriate labeled product that conforms to the requirements of the European Union IVD Directive (“IVDD”).

  • If AMI believes that required materials in countries not regulated by the IVD Directive must be translated into local language(s), the Parties promptly will discuss whether Celera will bear the cost of such translation(s).

  • Celera agrees to comply with all of the requirements of the IVD Directive and undertakes to ensure that the manufacture of the Celera Products is performed strictly in conformity with the requirements of the IVD Directive.