Vigilance Report definition

Vigilance Report means the incident report for death or serious injury required under the post market surveillance system as defined by the European Council Directive 93/42/EEC or the relevant and applicable equivalent of any other regulatory body.
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Examples of Vigilance Report in a sentence

  • ATS will notify GBI in writing if a Vigilance Report is required to be filed with respect to the Product.

  • In the event the Complaint involves a Medical Device Report or Medical Device Vigilance Report, for a Product, Buyer may require Seller to expedite the Complaint Investigation in order to comply with any applicable regulatory filing requirements.

  • HJL will notify LMAT in writing if a Vigilance Report is required to be filed with respect to the Product.

  • HJL will notify CL in writing if a Vigilance Report is required to be filed with respect to the Product.

  • ATS will notify Novare in writing if a Vigilance Report is required to be filed with respect to the Product.

Related to Vigilance Report

  • Variance Report shall have the meaning assigned to such term in Section 5.01(g).

  • Compliance Report means, as applicable in relation to the test being conducted, a report containing the results of the Compliance Tests carried out by State Street.

  • Benchmarking Report means the report produced by the Supplier following the Benchmark Review and as further described in this Framework Schedule 7;

  • Safeguards Monitoring Report means each report prepared and submitted by the Borrower to ADB that describes progress with implementation of and compliance with the EMP and the RP, including any corrective and preventative actions;

  • MI Report means a report containing Management Information submitted to the Authority in accordance with Framework Schedule 9 (Management Information);