UK-led pilot tests streamlined EU device incident reporting
This article was originally published in SRA
A new form for reporting medical device incidents is being tested in the EU that aims to make the current medical device vigilance system more efficient, transparent and effective1. The testing, when complete, will lead to the new manufacturer's incident report (MIR) form being incorporated into the EU guidance on medical device vigilance (MEDDEV 2.12/1).
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