European Medical Device Directive definition

European Medical Device Directive means the directive setting forth the safety and other requirements with which medical products marketed in European Union countries must comply (93/42/EEC).
Sample 1

Examples of European Medical Device Directive in a sentence

  • All existing products sold, marketed or distributed by the Company in Europe have CE Marking authorization under the European Medical Device Directive, as audited and approved by a European Notified Body.

  • For bringing the Aspect Products into the market in countries affected by the European Medical Device Directive ("MDD"), Aspect is the legally responsible manufacturer under the MDD.

  • Both parties agree to maintain ISO900x, EN460x, European directive 93/42/EEC Annex II ("MDD AX-II") certification status and compliance with the U.S. Food and Drug Administration's ("FDA") Quality System Regulation ("QSR"), the European Medical Device Directive ("MDD"), and other appropriate regulations pertinent to the development, manufacturing and marketing of medical products similar to the Aspect Products.

  • Moreover, because the European Medical Device Directive (the “MDD”) requires only minimum harmonization in the EU, member countries may alter their enforcement of the directives or amend their national regulatory rules.

  • MacroPore represents and warrants to Medicis that all Products sold under this Section 5.6 will have been manufactured, labeled, packaged and sold to Medicis in accordance with all applicable laws and regulations, including (as applicable) FDA GMP requirements, European Medical Device Directive requirements and ISO 9001 certification or successor requirements.

  • Both parties agree to maintain, as applicable, compliance with the U.S. Food and Drug Administrations ("FDA") Quality System Regulation ("QSR"), the European Medical Device Directive ("MDD"), and other appropriate regulations pertinent to the development, manufacturing and marketing of medical products similar to the Aspect Products.

  • Both Parties agree to maintain, as applicable, ISO13485, CAN/CSA-ISO 13485:03 certified by a Health Canada recognized Registrar, European directive 93/42/EEC Annex II (“MDD AX-II”) certification status and compliance with the U.S. Food and Drug Administration’s (“FDA”) Quality System Regulation (“QSR”), the European Medical Device Directive (“MDD”), and other appropriate regulations pertinent to the development, manufacturing and marketing of medical products similar to the BIS Products.

  • Both parties agree to maintain, as applicable, ISO900x or ISO13485, EN460x, European directive 93/42/EEC Annex II ("MDD AX-II") certification status and compliance with the U.S. Food and Drug Administration's ("FDA") Quality System Regulation ("QSR"), the European Medical Device Directive ("MDD"), and other appropriate regulations pertinent to the development, manufacturing and marketing of medical products similar to the Aspect Products.

  • Both parties shall comply in all material respects with all of their respective obligations under applicable federal, state and local laws including, without limitation, the Food, Drug and Cosmetic Act, the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and similar foreign laws, rules and regulations, including without limitation, the European Medical Device Directive.

  • The Company has ISO 9001 certification under the European Medical Device Directive and FDA clearance for certain surgical applications.

Related to European Medical Device 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:

  • EU means the European Union.

  • European Community means the territory comprised by the Member States of the European Community as constituted from time to time;

  • 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 Section 5.4 of this Contract, unless designated otherwise by the Province;

  • European Commission means the European Commission or any successor entity that is responsible for granting Marketing Approvals authorizing the sale of pharmaceuticals in the European Union.

  • 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;

  • MHLW means the Japanese Ministry of Health, Labor and Welfare, or a successor agency thereto.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • European Monetary System means the European Monetary System established by the Resolution of December 5, 1978 of the Council of the European Communities.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • European Communities means the European Economic Community, the European Coal and Steel Community and the European Atomic Energy Community.

  • 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;

  • StarCompliance Code of Ethics application means the web-based application used to electronically pre-clear personal securities transactions and file many of the reports required herein. The application can be accessed via the AB network at: https://alliance-ng.starcompliance.com/.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.