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Regulatory Affairs, Medical Devices

Manufacturing Incident Reports (MIR) under the EU MDR - WHITEPAPER


Download the exclusive whitepaper

With an increasing number of medical devices on the market, there is also an increasing number of incidents associated with them. The Manufacturer Incident Report (MIR) template for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) had its first version published by the EC in December 2018; and, since then, it has been revised twice.

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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