EU Medical Device definition

EU Medical Device means the European Union regulatory framework ensuring the safety and efficacy of medical devices and facilitates patients’ access to devices in the European Union market, including Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
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Examples of EU Medical Device in a sentence

  • SFI cannot take on the role of sponsor; therefore, appropriate sponsorship arrangements, satisfactory to SFI, must be made in compliance with relevant EU Clinical Trials Directives and related regulations, or, where relevant, the EU Medical Device Directives.

  • Bovie shall also comply with the essential requirements of the European health, safety and environmental protections legislations set forth in the European Union Council Medical Device Directives (the "EU Medical Device Directives") and declare such compliance by affixing the "CE Marking" to the Products shipped to Arthrex.

  • Notwithstanding the foregoing, Q-Med shall not be required to perform any development work to the extent a Licensed Product or any component thereof, in the Project as then proposed, is not a “device” under the FDCA or a “medical device” under the EU Medical Device Directive (93/42/EEC).

  • The new EU Medical Device Regulation due to replace the existing Directives sheds light on the importance of prioritizing safety and efficacy prior to achieving marketing approval, and on transparency of device information.

  • In order to better meet the requirements of regulatory bodies including:ñ FDA Quality System Regulations as set forth in 21 CFR PART 820,ñ Labeling instructions outlined in 21 CFR Part 810,ñ Canadian Medical Device Regulations (SOR/98-282),ñ EU Medical Device Directive (MDD 93/42/EEC),ñ And other applicable regulatory bodies A-M Systems has established documented, implemented and maintains a quality management system in accordance with the requirements of the ISO 13485:2016 Standard.

  • We received CE Marking in May 2016.In May 2017, a package of European Union legislation entered into force, replacing the existing regulatory framework for medical devices in the EEA, including for AIMD (the “New EU Medical Device Regulations”).

  • In 2021, the new EU Medical Device Regulation comes into force, requiring manufacturers to meet much more stringent requirements in their technical documentation and quality management systems.

  • In the EEA we must comply with the EU Medical Device Vigilance System, the purpose of which is to improve the protection of health and safety of patients, users and others by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.

  • The Company is complying in all material respects with all applicable regulatory post-market reporting obligations, including, without limitation, adverse event reporting requirements set forth by the EU Medical Device Directives, as applicable, and, to the extent applicable, their national implementing laws in the European Union member states.

  • EU Medical Device Regulation (MDR) (EU) No 2017/745 has been recasted in May, 2017, and specific substance listed in the below are restricted if medical devices contain these substances.10.4.1.(a) : Substances of categorized as Category 1A or 1B of Carcinogens (C), Mutagenicity (M) and Reproductive toxicity (R) in Part 3, Annex VI of CLP Regulation No. 1272/2008.

Related to EU Medical Device

  • 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:

  • Consumables and medical devices means (consumables) items that require regular replacement (e.g. batteries) to keep a medical device (such as a hearing aid) operational. Many medical devices require consumables.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

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

  • Pharmaceutical care means the provision of drug therapy and

  • 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.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

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

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

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

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Nuclear medicine technologist means an individual who holds a current certification with the American Registry of Radiological Technologists or the Nuclear Medicine Technology Certification Board.

  • Orthotic device means a custom-fitted or custom-fabricated medical device that is applied to a part of the human body to correct a deformity, improve function, or relieve symptoms of a disease.

  • Health Canada means the section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Therapeutic school means a residential group living facility:

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

  • 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.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • EUMA means the “SAP Delivered Support Agreement” which sets out the terms and conditions under which SAP provides support to End Users and which will be provided by SAP on a deal by deal basis.

  • Clinical Director means an individual who meets the minimum requirements set forth in Title 9, CCR, and has at least two (2) years of full-time professional experience working in a mental health setting.

  • Radiologic technologist, limited means an individual, other than a licensed radiologic technologist,

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Soil scientist means an individual duly qualified in accordance with standards set by the Federal Office of Personnel Management.