Module 16 2022

07/09/2022

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

• Change in scope of 3.1.2 to include IVF , ART, along with IVDs, and the consequences of potential errors by users. • 4.6. FSCA expanded to five notes from the single original note.. • Advice is given in 4.11 when an event could result in indirect harm

The Organisation for Professionals in Regulatory Affairs

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MEDDEV 2.12/1rev 8(based on rev 7 I Latest Version Forms MEDDEV 2.12 rev. 7 MIR and FSCA are still valid Active PDF forms How to use FSCA and MIR forms (* due form mancanti)

Other forms and templates Field safety notice template FSN customer reply FSN distibrutor/importer reply FSN Q&A Trend report Periodic summary report

The Organisation for Professionals in Regulatory Affairs

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