Actionable pathways to IVDR readiness and continued compliance

A row of many European Union flags wave in the wind.

Are you really ready for IVDR implementation? 

As a diagnostic developer, you know that the transition from the IVDD to the IVDR continues to be challenging. The slow rollout of implementing acts, harmonized standards, and guidance coupled with the lack of notified bodies continues to impact all stakeholders and adds risk to commercialization efforts. 

Beaufort has the expertise to effectively address your IVDR implementation challenges from quality system requirements to performance evaluation and through a product’s entire lifecycle. Our team will create a clear and actionable roadmap for existing and new products to meet the new regulations and guidances.

Transitional Provisions Timeline

Comprehensive IVDR Services

Beaufort provides strategic and technical guidance to assist with the implementation of any stage of the IVDR certification process, including:

  • Impact analysis/gap assessment
  • Transition strategies
  • Transitional provision requirements
  • Distance sales requirements
  • Standard operating procedure (SOP) and template development
  • Strategy for regulatory compliance
  • Device classification
  • Integration of unique device identifier (UDI) requirements
  • Risk management and benefit-risk analysis

  • Guidance on new clinical evidence requirements
  • Legacy product data review
  • Performance evaluation plan/Report (PEP/PER)
  • Analytical performance report
  • Clinical performance plan/Report
  • Scientific validity report
  • Clinical performance study plan (CPSP)
  • Companion diagnostic performance evaluation support including Annex XIV applications and EMA consultation procedure guidance

  • Intended purpose/Claim review
  • Labels and instructions for use requirements
  • Applicable standards
  • UDI requirements and symbols

  • Basic UDI, UDI device identifier (UDI-DI), and UDI production identifier (UDI-PI)
  • Device and actor registrations

  • Intended purpose development
  • Classification and coding/categorization (GIVD, GMDN, EMDN, NBOG)
  • Conformity assessment
  • Design and manufacturing information
  • General safety and performance requirements (GSPR) conformity assessment
  • Benefit-risk analysis and risk management
  • Product verification and validation
    • Performance evaluation planning and reporting
      • Analytical performance
      • Clinical performance
        • CPSP
      • Scientific validity

  • Post-market surveillance system – identification of inputs and dependencies
  • Post-market surveillance plan and report
  • Post-market performance follow-up (PMPF) plan and report
  • Periodic safety update report (PSUR)
  • Summary of safety and performance (SSP)

  • Reporting of serious incidents, including timeframes
  • Trending reporting
  • Analysis of serious incidents
  • Reporting of field safety corrective action (FSCA) and issuing of field safety notices (FSN)
  • Analysis of vigilance data

  • Person responsible for regulatory compliance (PRRC) requirements
  • Registration of economic operators (EOs) and devices
  • Control of suppliers (process/method)

  • Companion diagnostics
  • Self-testing
  • Near patient testing