The new template is intended to pave the way for an effective, efficient and transparent vigilance information exchange between manufacturers, Competent Authorities and Notified Bodies in the EU. This whitepaper looks at MIR under the EU MDR, including:
- Medical device vigilance system
- MIR v7.2: Reports, field actions and notices
- EUDAMED and SRNs: Delayed to May 2022
- Leveraging PMS to promote a safe benefit-risk profile of a product
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