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MDR Toolkit

EU Medical Device Regulation 2017/745 compliance

A complete documentation set for EU Medical Device Regulation (MDR) 2017/745 compliance, covering technical documentation, clinical evaluation, post-market surveillance and risk management.

What's inside

  • MDR technical documentation structure
  • Clinical evaluation and post-market clinical follow-up templates
  • Post-market surveillance system and vigilance records
  • Risk management file aligned to ISO 14971
  • UDI, labeling and economic operator documentation

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Download free demo samples

Preview the drafting quality of the MDR Toolkit with three real sample documents. Sign in and we'll email the full demo pack straight to your account address.

  • DOCX

    Control of Documents and Records Procedure

    An editable procedure for controlling, approving, updating and retaining EU MDR documents and records.

  • DOCX

    Design and Manufacturing Information Template

    A structured template for documenting the device design, manufacturing processes and supporting information.

  • DOCX

    Risk Management Plan Template

    An editable EU MDR risk management plan covering responsibilities, criteria, activities and review requirements.

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