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Adverse incident reporting pilot programme extended

This article was originally published in Clinica

Executive Summary

A six-month pilot programme of an EU initiative for the electronic exchange of adverse incident reports between manufacturers/distributors and medtech regulatory authorities has been extended. The programme began in January this year, with four EU countries taking part: Ireland, Germany, France and the UK. The aim of the programme is to evaluate the electronic submission of incidents which fit within the reporting criteria of the European Commission’s vigilance guidance document, meddev 2.12/1 revision 5.

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