Preparing for Europe’s New In Vitro Diagnostic Medical Device Regulation

The Essential Guide to EU IVDR Compliance

Section 4: Steps For A Successful EU IVDR Implementation

  1. Assign a dedicated team to oversee the IVDR transition
  2. Perform a gap assessment to determine the IVDR impact on your existing product portfolio, quality management system (QMS), and internal resources
    • Determine your responsibilities as an economic operator (i.e., manufacturer) under the new IVDR
    • Confirm the classification of your devices. Do any of them require reclassification under the new regulation?
    • Determine if you will need to collect additional data to meet the new performance evaluation and/or post-market surveillance requirements or conduct new clinical performance studies
    • Identify any documentation or processes that need to be updated and/or added to your QMS and technical file
    • Review current supply chain activities and contracts. How will your supply chain be impacted by the new requirements? What changes are needed?
    • Assess time, resources, and costs that will need to be allocated to certifying your medical devices under the new regulation
    • Determine how the IVDR compliance costs will impact your future revenue and return on investment (ROI)
  3. Contact your respective notified body to gain an understanding of its IVDR designation status. If it has not yet gained a designation, you may need to seek out a different notified body. If it is already designated, obtain some clarification regarding its scope of designation and timelines.
    • Does the scope of designation cover your entire product portfolio?
    • When will the notified body be ready to review your technical documentation?
    • How long will it take for the notified body to complete its review?
  4. Formulate an IVDR transition plan, timeline, and budget based on the findings from your gap assessment and notified body
  5. Review the General Safety and Performance Requirements as outlined in Annex I of the IVDR to determine the requirements that are applicable to your medical device
  6. Develop and implement a risk management plan in accordance with ISO 14971
  7. Plan and coordinate performance studies as needed
  8. Establish your plan and processes for performance evaluation and post-market performance follow-up (PMPF)
  9. Establish your plan and processes for post-market surveillance (PMS)
  10. Ensure the proper labeling is in place for your medical device(s), including the creation of unique device identifiers (UDIs)
  11. Access the EUDAMED database (Actor Registration Module) to register as an economic operator (e.g., manufacturer) and obtain a single registration number (SRN)
  12. Ensure that the proper agreements between authorized representatives, importers, and distributors are in place
  13. Update your technical file and QMS according to the new IVDR requirements
  14. Conduct company-wide training and involve key stakeholders in the IVDR implementation and new QMS requirements. Build additional teams as needed
  15. Conduct a series of internal audits to verify that all requirements are met under the new IVDR prior to your official inspection/recertification