MEDDEV guidance
List of all the MEDDEVs, the European Commission’s official guidance for Medical Devices. This European guidelines are useful for Medical Device manufacturers, Notified Bodies and Competent Authorities.
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MEDDEV 2.5/5 rev.3 Translation procedure
February 1998
MEDDEV 2.5/6 rev.1 Homogenous batches
February 1998
MEDDEV 2.12/1 Report Form: Field Safety Corrective Action
December 2012 – Please open in a pdf app.
MEDDEV 2.12/1 Manufacturer Incident Report: MDR/IVDR (Serious Incidents) & (AI)MDD/IVDD (Incidents)
v7.2.1 – Please open in a pdf app.
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