Module 16 2022

07/09/2022

MEDDEV 2.12/1rev 8(based on rev 7)

II. Device Specific Vigilance Guidance DSVG Template/DSVG 00/DSVG 01/DSVG 02 New MIR form – as from January 2019 New manufacturer incident report New manufacturer incident report for importing XML file with Adobe Professional The published MIR form is password-protected so it may be necessary to unlock it for specific purposes (e.g. translating the form, implementing it into in-house IT systems).

The Organisation for Professionals in Regulatory Affairs

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Developments with MEDDEV 2.12/1

• Systematic data collection of similar incidents per country, Europe and worldwide • Systematic use of mechanistic knowledge and reasoning in regulatory toxicology (EC DG Joint Research Centre, Institute for Health and Consumer Protection,I 21027 Ispra, Italy.)

The Organisation for Professionals in Regulatory Affairs

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