Directive 93/42 definition

Directive 93/42 means Council Directive 93/42/EEC of 14th June 1993 concerning medical devices(3), as amended(4);
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Examples of Directive 93/42 in a sentence

  • This book is also intended to technicians in charge of maintenance equipment.This Instruction Booklet should always follow the equipment and must be carefully preserved in order not to compromise its readability.In case of transfer to third parties this manual has to be transmitted with other documents as required by European Directive 93/42 EEC.

  • According to the MDD, a medical device is a device intended to be used for certain medical purposes listed in the MDD (Directive 93/42).

  • This increased scale, in turn, will enable Charter to spread those fixed costs over more customers, enhancing Charter’s ability and incentive to invest in the development and deployment of innovative new technologies.

  • This device conforms to the European Directive 93/42 EEC for Medical Products.

  • The requirements our suppliers have to satisfy are taken for the most part from the newest versions of DIN EN ISO 13485, DIN EN ISO 9001 and EC Directive 93/42 EEC.

  • With respect to the R2 Product, R2, at its expense, will be responsible for obtaining and maintaining, in R2’s name: (a) FDA and other applicable United States regulatory agency approvals; (b) ISO9000 certification; (c) CE certification in accordance with the provisions of Directive 93/42 governing medical devices for the R2 Product; and (d) applicable regulatory approvals in Canada.

  • In this Regulation, any reference to Annex 8 to Directive 90/385 or to Annex XI to Directive 93/42 is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A to the Medical Devices Regulations 2002.”.

  • The foregoing analysis has important consequences for the eHealth services industry in the EU, because eHealth services and specifically the software provided for the the- rapeutic and/or diagnostic functionalities may very well constitute medical devices in the meaning of Directive 93/42 (“MDD”) as amended [6].

  • EU legislationThis product is a medical device according to EC Directive 93/42.

  • The EU is currently transitioning from the Medical Device Directive 93/42 (Council of the European Union, 1993) to the Medical Device Regulations 2017/745 (Council of the European Union, 2017), which all medical devices must meet by May 2020.

Related to Directive 93/42

  • 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 (UCITS) recast, including the associated implementing measures contained in Directive 2010/43/EU and Directive 2010/44/EU, and as amended by Directive 2014/91/EU of the European Parliament and of the Council of 23 July 2014, and as may be further amended from time to time;

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

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

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

  • Directive means EC Council Directive 2001/23/EC

  • 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”.

  • 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.

  • Mobile crisis outreach team means a crisis intervention service for minors or families of minors experiencing behavioral health or psychiatric emergencies.

  • 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.

  • Local Mental Health Authority means a county legislative body.

  • 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.

  • Antipsychotic medications means that class of drugs

  • 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;

  • 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.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • Designated crisis responder means a mental health

  • Health Authority means the regional health board designated under the Health Authority Act, RSBC 1996, c.180, or the Provincial Health Services Authority, to which the Participant is designated under Schedule 1 (Return of Service Placement Process) of this Contract, unless designated otherwise by the Province;

  • Elective Treatment and Procedures means any medical treatment or surgical procedure that is not medically necessary, including any service, treatment, or supplies that are deemed by the federal, or a state or local government authority, or by Us to be research or experimental or that is not recognized as a generally accepted medical practice.

  • Mental health facility means a mental health facility as defined by the Inpatient Mental Health Treatment of Children Act;

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

  • 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.

  • Mental Health Worker means an individual that assists in planning, developing and evaluating mental health services for Clients; provides liaison between Clients and service providers; and has obtained a Bachelor's degree in a behavioral science field such as psychology, counseling, or social work, or has two years of experience providing client related services to Clients experiencing mental health, drug abuse or alcohol disorders. Education in a behavioral science field such as psychology, counseling, or social work may be substituted for up to one year of the experience requirement.

  • Adult abuse means the willful infliction of physical pain, injury or mental anguish or unreasonable

  • Explosives or munitions emergency response specialist means an individual trained in chemical or conventional munitions or explosives handling, transportation, render-safe procedures, or destruction techniques. Explosives or munitions emergency response specialists include Department of Defense (DOD) emergency explosive ordnance disposal (EOD), technical escort unit (TEU), and DOD-certified civilian or contractor personnel; and other Federal, State, or local government, or civilian personnel similarly trained in explosives or munitions emergency responses.

  • 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.