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.

Related to CE Marked

  • CE marking means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

  • Principal Trading Market means the national securities exchange or other trading market on which the Common Stock is primarily listed on and quoted for trading, which, as of the Original Issue Date, shall be the Nasdaq Global Select Market.

  • JOBURG MARKET means Johannesburg Fresh Produce Market (SOC) Limited (trading as Joburg Market), a corporatized municipal entity incorporated in terms of the laws of the RSA under registration number 2000/023383/07 and with VAT registration number 4840195038, with its domicilium citandi et executandi situated at The Office of the CEO, 3rd Floor, Main Building, Joburg Market, 4 Fortune Road (off Heidelberg Road), City Deep, 2049, Johannesburg.

  • Transient space marketplace means an online marketplace through which a person may offer transient accommodations or hotel rooms to individuals. A “transient space marketplace” allows transient accommodations or hotel rooms to be advertised or listed through an online marketplace 1[and] in exchange for consideration or1 provides a means for a customer to arrange for the occupancy of the transient accommodation or hotel room in exchange for consideration 1[directly through the online marketplace]. A ‘transient space marketplace’ shall not include an online marketplace operated by or on behalf of a hotel or hotel corporation that facilitates customer occupancy solely for the hotel or hotel corporation’s owned or managed hotels and franchisees.1

  • online marketplace means a service using software, including a website, part of a website or an application, operated by or on behalf of a trader which allows consumers to conclude distance contracts with other traders or consumers;