Directive 98/79 definition

Directive 98/79 means Directive98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro diagnostic medical devices(5);
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Examples of Directive 98/79 in a sentence

  • Annexes V and VII;(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and(c) ensures that the device meets the provisions of Directive 98/79 which apply to it.

  • The Secretary of State shall perform, as respects the United Kingdom, the functions of the Member State under article 8 of Directive 90/385, article 10 of Directive 93/42 and article 11(1) to(3) of Directive 98/79.

  • Annex V and either Annex VI or Annex VII; (b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and (c) ensures that the device meets the provisions of Directive 98/79 which apply to it.

  • The project is not subject to the Buffer and Setback Guidelines as it proposes parking only, which is an approved use within a buffer area.

  • This CE marking may be affixed to an in vitro diagnostic medical device only if it complies with the essential requirements and has been the subject of the evaluation procedures applicable to it.All of the essential requirements and conditions for compliance are described in Regulation (EU) No.2017/746 of 5 April 2017 on in vitro diagnostic medical devices repealing Directive 98/79 EC and Commission Decision 2010/227/EU.

  • If we opt to make the one-time payment in cash, ColoAlert AS has the right to require us to pay the €4,000,000 in ordinary shares at the valuation of our most recent financing.In the European Union, ColoAlert is a CE-IVD registered product under the current In-Vitro Diagnostics Directive 98/79 /EC (“IVD-D”).

  • In order to be compliant with this criterion bidder will be requested to provide one of the following pre-market approval(s) / market clearance(s)/registration(s): A.1. CE mark (EU), (Directive 93/42 EEC or Directive 98/79 EEC), orA.2. Registration No. issued by the Medicines and Medical Devices Agency of the Republic of Moldova;(A.3. is deleted) 2.1.2. B.

  • Its use by the In Vitro Diagnostic (IVD) industry and laboratorians is now recommended by the European Directive 98/79 EC [87] and the ISO 15189 stand- ard [88, 89].In contrast, the application of the concept remains difficult in clinical and laboratory practice: procedures for estimating reference limits need to be improved.

  • In order to be compliant with this criterion bidder will be requested to provide one of the following pre-market approval(s) / market clearance(s)/registration(s): A.1. CE mark (EU), (Directive 93/42 EEC or Directive 98/79 EEC), orA.2. Registration No. issued by the Medicines and Medical Devices Agency of the Republic of Moldova.

  • These characteristics cause ischemics through the pressure to a skin, and develop the pressure ulcer to the skin.

Related to Directive 98/79

  • Council Directive means Council Directive 89/552/EEC of 3 October 1989 on the co-ordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities as amended by Directive 97/36/EC of the European Parliament and of the Council of 30 June 1997 and by Directive 2007/65/EC of the European Parliament and of the Council of 11 December 2007. A simplified and codified version of these Directives was introduced in 2010: the Audiovisual Media Services Directive 2010/13/EU.

  • 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);

  • Directive means EC Council Directive 2001/23/EC

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

  • Labor law decision means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

  • 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;

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

  • Industrial Emissions Directive means DIRECTIVE 2010/75/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 November 2010 on industrial emissions

  • 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.

  • Environmental, Health or Safety Requirements of Law means all Requirements of Law derived from or relating to foreign, federal, state and local laws or regulations relating to or addressing pollution or protection of the environment, or protection of worker health or safety, including, but not limited to, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq., the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., and the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., in each case including any amendments thereto, any successor statutes, and any regulations or guidance promulgated thereunder, and any state or local equivalent thereof.

  • Solvency II Directive means Directive 2009/138/EC of the European Parliament and of the Council of the European Union of 25 November 2009 on the taking-up and pursuit of the business of insurance and reinsurance (Solvency II);

  • Capital Requirements 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, as amended or replaced from time to time.

  • Administration of criminal justice means performance of any activity directly involving the

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, and ordinances concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, as such requirements are enacted and in effect on or prior to the Closing Date.

  • Construction Change Directive means a written order prepared by Owner Parties and signed by Owner directing Contractor to perform a change in the Work prior to agreeing to a change, if any, to the Contract Time, schedule of performance of the Work, Contract Sum, or Contractor’s compensation.

  • Environmental and Social Management Framework or “ESMF” means the framework disclosed in country on September 13, 2010 and at the Association’s Infoshop on September 14, 2010, in form and substance satisfactory to the Association, setting out modalities to be followed in assessing the potential adverse environmental and social impact associated with activities to be implemented under the Project, and the measures to be taken to offset, reduce, or mitigate such adverse impact.

  • Municipal Finance Management Act means the Local Government: Municipal Finance Management Act, 2003 (Act No. 56 of 2003);

  • Environmental and Social Management Plan or “ESMP” means a site-specific environmental and social management plan to be prepared in accordance with the parameters laid down in the ESMF and acceptable to the Association, setting forth a set of mitigation, monitoring, and institutional measures to be taken during the implementation and operation of the Project activities to eliminate adverse environmental and social impacts, offset them, or reduce them to acceptable levels, and including the actions needed to implement these measures.

  • Environmental, Health and Safety Laws means the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Resource Conservation and Recovery Act of 1976, and the Occupational Safety and Health Act of 1970, each as amended, together with all other laws (including rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings, and charges thereunder) of federal, state, local, and foreign governments (and all agencies thereof) concerning pollution or protection of the environment, public health and safety, or employee health and safety, including laws relating to emissions, discharges, releases, or threatened releases of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes into ambient air, surface water, ground water, or lands or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Health and Human Services Commission or “HHSC” means the administrative agency established under Chapter 531, Texas Government Code, or its designee.

  • Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products;

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

  • 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.

  • Department of Health and Human Services means the Department of Health and Human Services

  • 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.