CE Marking/Premarket Clearance Sample Clauses

CE Marking/Premarket Clearance. Each Product owned or distributed by the Company and in current commercial distribution is in compliance in all material respects with applicable marketing authorization, conformity assessments and quality systems requirements of the relevant country, and, in the EU member states, is marketed under, and is covered by, a medical device CE xxxx. Each Product is marketed in compliance with the regulatory requirements in each country where the Product is commercialized, and in the EU member states, on the basis of which the CE xxxx was affixed under the following EU legislation: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the EU member states relating to electromagnetic compatibility and repealing Directive 89/336/EEC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of EU member states relating to electrical equipment designed for use within certain voltage limits and any applicable national legislation in any EU member state implementing Council Directive 93/42/EEC, Directive 2004/108/EC and Directive 2006/95/EC.
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CE Marking/Premarket Clearance. Each Product owned or distributed by the Company and in current commercial distribution in (A) outside the U.S. is in compliance in all material respects with applicable marketing authorization and quality systems requirements of the relevant country, and (B) in the EU is a Class I, IIa or IIb medical device as defined under the MDD (and applicable EU guidelines and Member State requirements), and was marketed under, and is covered by, a CE marking following the Company’s compliance in all material respects with the requirements under the MDD and other Applicable Non-U.S. Laws and Regulations including compliance in all material respects, in manufacture, with ISO/CEN 13485 (on quality systems). Each Product that includes cells or tissues marketed outside the U.S. is marketed in compliance in all material respects with any applicable marketing authorization and good manufacturing practice (or quality system) requirements.
Sample 1
CE Marking/Premarket Clearance. Each Product owned or distributed by the Company and in current commercial distribution is in compliance in all material respects with applicable marketing authorization and quality systems requirements of the relevant country, and, in the EU member states, is marketed under, and is covered by, a CE xxxx. Each such Product has been determined by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) not to be subject to the provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended. Each Product is marketed solely in compliance with the legislative provisions on the basis of which the CE xxxx was affixed under the following EU legislation: Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the EU member states relating to electromagnetic compatibility and repealing Directive 89/336/EEC and Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of EU member states relating to electrical equipment designed for use within certain voltage limits and any applicable national legislation in any EU member state implementing Directive 2004/108/EC and Directive 2006/95/EC.
Sample 1

Related to CE Marking/Premarket Clearance

  • HSR Clearance All applicable waiting periods under the HSR Act shall have expired or been terminated.

  • Customs Clearance 1. The Parties shall apply their respective customsprocedures in a predictable, consistent, and transparentmanner. 2. For prompt customs clearance of goods traded between theParties, each Party shall: (a) endeavor to make use of information and communications technology; (b) simplify its customs procedures; (c) harmonize its customs procedures, as far as possible,with relevant international standards and recommended practices such as those made under the auspices of theCustoms Co-operation Council; and (d) promote cooperation, wherever appropriate, betweenits customs authority and: (i) other national authorities of the Party; (ii) the trading communities of the Party; and (iii) the customs authorities of non- Parties. 3. Each Party shall provide affected parties with easilyaccessible processes of administrative and judicial review ofits administrative actions relating to customs matters.

  • FINRA Clearance On or before the date of this Agreement, the Representative shall have received clearance from FINRA as to the amount of compensation allowable or payable to the Underwriters as described in the Registration Statement.

  • NASD Clearance By the Effective Date, the Representative shall have received clearance from the NASD as to the amount of compensation allowable or payable to the Underwriters as described in the Registration Statement.

  • Exchange Clearance On the Closing Date, the Firm Shares shall have been approved for listing on the Exchange, subject only to official notice of issuance. On the first Option Closing Date (if any), the Option Shares shall have been approved for listing on the Exchange, subject only to official notice of issuance.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Security Clearance 6.7.1 Where specified by the Authority or the Contract user, the Supplier shall be responsible for ensuring that all Staff are security cleared to the level required by the Security Requirements not less than 5 Working Days before such person begins to perform the Services. If the Authority is responsible for applying for security clearance for Staff pursuant to this Clause 6.7.1, the Supplier shall provide a completed security clearance application form for such members of Staff to the Authority not less than 30 days before such members of Staff begin to perform the Services. 6.7.2 The Authority shall issue a pass for all Staff who are security cleared to an appropriate level for the Premises in accordance with Clause 6.7.1 on or before the date when such member of Staff is required to enter onto the Premises in Order to perform the Services. Passes shall remain the property of the Authority and shall be surrendered on demand or on termination or expiry of this Contract. 6.7.3 A member of Staff not in possession of a pass who is required by the Supplier or any Sub-contractor to provide the services urgently shall be allowed temporary access to the Premises on condition that the Supplier ensures, or procures that any Sub- contractor shall ensure, that such individual is accompanied at all times while on the Premises by a member of Staff who has been issued with a pass in accordance with Clause 6.7.1. 6.7.4 Without prejudice to the provisions of Clauses 6.7.1 to 6.7.3 inclusive, the Authority may refuse any member of Staff Admission to the Premises or require the removal of any member of Staff from the Premises in accordance with Clause 3.3 if such member of Staff is not in possession of a pass pursuant to Clause 6.7.2 or accompanied in accordance with Clause 6.7.3.

  • Contractor Security Clearance Customers may designate certain duties and/or positions as positions of “special trust” because they involve special trust responsibilities, are located in sensitive locations, or have key capabilities with access to sensitive or confidential information. The designation of a special trust position or duties is at the sole discretion of the Customer. Contractor or Contractor’s employees and Staff who, in the performance of this Contract, will be assigned to work in positions determined by the Customer to be positions of special trust, may be required to submit to background screening and be approved by the Customer to work on this Contract.

  • Exchange Stock Market Clearance On the Closing Date, the Company’s shares of Common Stock, including the Firm Shares, shall have been approved for listing on the Exchange, subject only to official notice of issuance. On the first Option Closing Date (if any), the Company’s shares of Common Stock, including the Option Shares, shall have been approved for listing on the Exchange, subject only to official notice of issuance.

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