CE-IVD definition

CE-IVD means approved CE Marking according to the Requirements of European Directive 98/79/EC of the European Parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices (IVDD) or its successor Directive.
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CE-IVD means in vitro diagnostic CE marked products " CE mark " or "CE marked" means a certification mark that indicates conformity with health,safety, and environmental protection standards for products sold within the European Economic Area "certificated form" or "in certificated form" means recorded on the relevant register of the share or securityconcerned as being held in certificated form (that is not in CREST) " Company " or " Yourgene " or "Yourgene Health" means Yourgene Health plc, a company registered in England and Wales with registration number 03971582 "Conditions" means the conditions set out in clause 2 of the PlacingAgreement " Consideration Shares" means the new Ordinary Shares to be issued by the Company tothe shareholders of Elucigene pursuant to the Acquisition Agreement
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Examples of CE-IVD in a sentence

  • Licensee shall pay Licensor a one-time non-refundable, non-creditable payment of USD $[***] upon launch of the first IVD product (i.e., cleared or approved by the United States Food and Drug Administration or certified as CE-IVD in the European Union).

  • Each Party shall be responsible for its own cost related to the further development of the ColoAlert Technology and CE-IVD approval (when needed) and cost of sales of the Licensed Kits, unless otherwise agreed in writing between the PartiesCollaboration committee The Parties shall form a collaboration committee with a responsibility to monitor the development of the ColoAlert Technology and the commercialization of said technology on a monthly basis.

  • Company acknowledges that currently, LTC is seeking Approval for CE-IVD marking of the LTC Dx Product, but such Approval has not been received as of the Effective Date, and that the LTC Dx Product will not be available under this Agreement until such Approval is received.

  • Development, as it pertains to VeriStrat in connection with Ficlatuzumab, means non-clinical (including pre-clinical) and clinical assay development, related research, analytical development and validation and regulatory submission activities, including development and submission of a PMA or CE-IVD submission to be filed with the relevant Regulatory Authority.

  • As regards the possibility of increasing the Purchase Price pursuant to Clause 5.1.1, the Parties agree to the following milestone (hereinafter, “Milestone I”): Fulfilment of the prerequisites and first-time CE/IVD designation for the Gyronimo Platform and its first Application Cartridge, via issuance of a conformity declaration or, if required, via a Certification Body.