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.

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.