EU Medical Devices Directive definition

EU Medical Devices Directive means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended or supplemented from time to time.
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Examples of EU Medical Devices Directive in a sentence

  • Definitions of the medical devices aggregate:▪ Eucomed: the reference definition corresponds to that of the EU Medical Devices Directive (93/42/ECC); the figures are from Eucomed's calculations and estimations based on their data sources, reported in Eucomed (2003, see the Appendix; or at http://www.eucomed.be/docs/Overview%20sources.pdf).▪ Standard & Poor’s: “.

  • The requirements for the UKCA for medical devices are based on the requirements set out in the EU Medical Devices Directive (93/42/EEC), rather than the Medical Devices Regulation that applies in the European Union and has repealed the directive.

  • This is achieved by requiring a manufacturer to demonstrate compliance with the relevant EU Medical Devices Directive which has, in turn, been replicated in legislation in each of the member states.

  • The MT10 Tympanometer is classified as a Class II a device under Annex IX (Section 1) of the EU Medical Devices Directive.

  • The EU Medical Devices Directive (MDD) operates a vigilance system as a process of notification and evaluation of adverse incidents involving medical devices.

  • Further, the advertising and promotion of our products is subject to EEA Member States laws implementing Directive 93/42/EEC concerning Medical Devices, or the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State legislation governing the advertising and promotion of medical devices.

  • The Package Insert is in compliance with the EU Medical Devices Directive (93/42/EEC), and is subject to an annual review by the designated EU Notified Body.

  • This clinical investigation will be conducted in compliance with the principles that have their origin in the latest version of the Declaration of Helsinki; this clinical investigation plan; U.S. 21 CFR Parts 50, 56 and 812; requirements of the approving IRBs/EC and competent authorities, including the U.S. FDA; ISO 14155:2011; the EU Medical Devices Directive 93/42/EEC Annex X– Clinical Evaluation; and other applicable regulatory requirements, whichever provides the greater protection of the individual.

  • Conforms to EU Medical Devices Directive 93/42/EEC, Class I and EN 14683 standard for type IIR (or equivalent international standard).

  • Depending on the risk classification of the app under the EU Medical Devices Directive, this may also entail an assessment of the technical documentation and the manufacturer’s quality system by a Notified Body (designated by the competent authority).

Related to EU Medical Devices Directive

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • 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.

  • 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;

  • 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.

  • HITECH means the Health Information Technology for Economic and Clinical Health Act.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Clinical supervision means direction or oversight provided either face to face or by videoconference or telephone by an individual qualified to evaluate, guide, and direct all behavioral health services provided by a licensee to assist the licensee to develop and improve the necessary knowledge, skills, techniques, and abilities to allow the licensee to engage in the practice of behavioral health ethically, safely, and competently.

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;

  • Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.

  • Rural health clinic means a rural health clinic as defined under section 1861 of part C of title XVIII of the social security act, chapter 531, 49 Stat. 620, 42 U.S.C. 1395x, and certified to participate in medicaid and medicare.