IVD Directive definition

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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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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Examples of IVD Directive in a sentence

  • Pending implementation of the new IVDR in 2022, all IVDs used for NPT are currently regulated under the IVD Directive 98/79/EC2.

  • Its role is to ensure that all IVDs placed on the Irish market comply with the essential requirements of the IVD Directive and related national legislation.

  • According to the IVD Directive (98/79/EC) both software and kits for the additional analytes must be suitable for trisomy 21 screening and CE-certified by a notified body, indicated by the identification number of the notified body on the CE-mark on software and kits.

  • For IVDs listed in Annex II, the IVD Directive also makes provision for the adoption of Common Technical Specification (CTS) which shall establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials.

  • NOTE 6:This guideline uses the definition of FSCA as synonym for recall mentioned in article 10, paragraph 1b) of the MDD, Article 8, paragraph 1b) of the AIMD and Article 11, paragraph 1b) of the IVD Directive.

  • According to section FR 2.7, starting platforms must be rigid with no spring.

  • Under the EU IVD Directive, the emphasis was on analytical performance data.

  • 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.

  • 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.

  • The GHTF guidance document GHTF/SG1/N046:2008 entitled "Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices", adopted on 31 July 20087, sets out the elements of conformity assessment applicable to the different classes of IVDs. In addition, the current IVD Directive requires the verification of manufactured devices covered by Annex II, List A ("batch release verification").

Related to IVD Directive

  • CRD Directive means the Directive (2013/36/EU) of the European Parliament and of the Council on prudential requirements for credit institutions and investment firms dated 26 June 2013 and published in the Official Journal of the European Union on 27 June 2013 (or, as the case may be, any provision of Danish law transposing or implementing such Directive), as amended or replaced from time to time (including, for the avoidance of doubt, the amendments to such Directive resulting from Directive (EU) 2019/878 of the European Parliament and of the Council as regards exempted entities, financial holding companies, mixed financial holding companies, remuneration, supervisory measures and powers and capital conservation measures dated 20 May 2019 and published in the Official Journal of the European Union on 7 June 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

  • Advance health care directive means a power of attorney for health care or a record signed or authorized by a prospective donor containing the prospective donor’s direction concerning a health care decision for the prospective donor.

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

  • Waste Framework Directive or “WFD” means Waste Framework Directive 2008/98/EC of the European Parliament and of the Council on waste.

  • 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 means a requirement for the Inspection, repair or modification of the Engine or any portion thereof as issued by Airworthiness Authorities.

  • 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.

  • Medical direction means direction, advice, or orders provided by a medical director, supervising physician, or physician designee (in accordance with written parameters and protocols) to emergency medical care personnel.

  • Qualified medical direction means, in the context of the practice of respiratory care, having readily

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

  • College board means the state board for community and

  • Clinical supervisor means any of the following:

  • 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.

  • Medically Necessary Treatment means any treatment, tests, medication, or stay in hospital or part of a stay in hospital which:

  • Independent Safeguarding Authority is a non-departmental public body sponsored by the Home Office set up under the provisions of the Safeguarding Vulnerable Groups Act 2006 and which is responsible for the decision making and maintenance of two lists covering the children’s and vulnerable adults’ sectors

  • Participating Clinical Social Worker means a Clinical Social Worker who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

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

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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;

  • Uniform Grant Management Standards or “UGMS” means uniform grant and contract administration procedures, developed under the authority of Chapter 783 of the Texas

  • Non-Participating Clinical Social Worker means a Clinical Social Worker who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Legislative Leadership Committee means a committee established, authorized to be established, or designated by the President of the Senate, the Minority Leader of the Senate, the Speaker of the General Assembly, or the Minority Leader of the General Assembly pursuant to N.J.S.A. 19:44A-10.1 for the purpose of receiving contributions and making expenditures.