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

  • 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.

  • 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.

  • 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).

  • According to the IVD Directive, EU Member States have presumed compliance with these essential requirements for devices that are in conformity with the relevant national standards transposing the harmonized standards, such as ISO 13485:2016, the quality system standard for medical device manufacturers.IVD medical devices, other than devices for performance evaluation, must bear the CE marking of conformity when they are placed on the European market.

  • The IVD Directive required that medical devices meet the essential requirements, including those relating to device safety and efficacy, set out in an annex of the Directive.

  • Unlike the IVD Directive, the IVDR has binding legal force throughout every Member State.

  • Under the IVD Directive the majority of QIAGEN products were classified as self-declared, while under IVDR most of QIAGEN products will require pre-approval, and those that are in the highest risk class will have to be tested by a Designated Reference Laboratory.

  • European Union RegulationsIn the European Union, in vitro diagnostic medical devices (IVDs) had been regulated under EU-Directive 98/79/EC (IVD Directive) and corresponding national provisions.

  • 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.

Related to IVD Directive

  • CRD Directive means Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (as amended from time to time, including by Directive (EU) 2019/878 of the European Parliament and of the Council of 20 May 2019);

  • UCITS Directive means Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities, as amended;

  • CRD IV Directive means Directive 2013/36/EU on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms of the European Parliament and of the Council of 26 June 2013, as the same may be amended or replaced from time to time.

  • Change Directive means a written order signed by the procurement officer that

  • the Directive means Council Directive 2003/4/EC(d) on public access to environmental information and repealing Council Directive 90/313/EEC;

  • Acquired Rights Directive means the European Council Directive 77/187/EEC on the approximation of laws of European member states relating to the safeguarding of employees’ rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses, as amended or re-enacted from time to time;

  • Airworthiness Directive or “AD” means any airworthiness directive issued by the Certificating Authority, in addition to any airworthiness directive issued by the Aeronautics Authority, each to the extent the same is applicable to the Aircraft and/or any Item of Equipment.

  • Directives means intergovernmental, interagency, or interdepartment administrative or procedural guidelines or instructions which do not affect the rights of, or procedures and practices available to, the public.

  • Advance directive means a document that contains a health care instruction or a power of attorney for health care.

  • Directive means EC Council Directive 2001/23/EC

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • Ethics Committee means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;