CE Marked definition

CE Marked means bearing the CE ▇▇▇▇ to indicate compliance of the medical device with the essential requirements of Council Directive 93/42/EEC concerning medical devices or Council Directive 90/385/EEC concerning active implantable medical devices. A CE marked medical device may be placed on the market and put into service in the EU for its intended purpose.
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CE Marked means bearing the CE Mark to indicate compliance of the medical device with the essential requirements of Council Directive 93/42/EEC concerning medical devices, Council Directive 90/385/EEC concerning active implantable medical devices, or Regulation (EU) 2017/745 concerning medical devices. In this Agreement, CE Marked should also be construed to include reference to UKCA Mark or CE and UKNI Mark, as applicable to the country of the UK in which the Trial Site is established. A CE-marked medical device may be placed on the market and put into service in the UK for its intended purpose; Clinical Investigation means the investigation to be conducted at the Trial Site in accordance with the Clinical Investigation Plan; Clinical Investigation Completion means the conclusion of all Clinical Investigation Plan required activities for all enrolled Participants in all locations where the Sponsor (or any Affiliate of the Sponsor) is carrying out the Clinical Investigation described in the Clinical Investigation Plan; Clinical Investigation Monitor means one or more persons appointed by the Sponsor, or Affiliate, to monitor compliance of the Clinical Investigation with BS EN ISO 14155:2020 and to conduct source data verification; Clinical Investigation Plan means the full description of the Clinical Investigation with the reference number set out on the front page of this Agreement, together with any Amendments thereof made in accordance with Clause 16.3, and incorporated into this Agreement by reference;
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CE Marked means CE marking in accordance with the In Vitro Diagnostics Directive (IVDD) 98/79/EC.
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Examples of CE Marked in a sentence

  • Products are CE Marked to the harmonised standard relating to performance characteristics for windows and doors – BS EN 14351-1.

  • Distributor shall assist SynCardia in complying with applicable Quality System Requirements as detailed by (i) U.S. FDA, (ii) European Union (CE Marked) or (iii) the regulatory governing body within the Distributor’s country(ies) of origin in the Territory, as amended from time to time.

  • The Sponsor may defer registration until thirty (30) days after the date that the Investigational Medical Device is CE Marked for the intended purpose being investigated.

  • All products are CE Marked in accordance with the Construction Products Regulation 2011 where relevant.

  • OSI shall be responsible for the CE ▇▇▇▇ approval for the complete hip system that will be utilized in concert with Amedica’s CE Marked femoral components.

  • With respect to those components which are CE Marked or otherwise cleared for sale in other jurisdictions as of the Effective Date, or which will be so cleared during the term of this Agreement, the Parties agree to [***]for marketing and sale of the Products, and to take all necessary steps [***] as soon as practicable.

  • ISO Certified, CE Marked and FDA Approved (Make USA, Europe, Japan) Detailed Requirements: ⮚ Minimum 100 tests on panel including Chemistry and Immunoassay ⮚ Sample loading capacity more than 400 Samples at once with continuous loading option.

  • Except as disclosed in Schedule 4.1(u)(i), each NeoGraft Device sold in Europe in the five years prior to 2017, were CE Marked and fully authorized to be on the market.

  • Test Article: ACRYSOF IQ PanOptix Presbyopia-Correcting IOL Model TFNT00 The TFNT00 IOL is a CE Marked device that is commercially available in the countries of the participating Investigators as well as other countries across the globe.

  • Without a single needle stick, the company's FDA approved and CE- Marked T-line technology is used today in hospital operating rooms, ICUs and electrophysiology labs to provide a patient's real-time pulse pressure waveform and blood pressure.