Association for Molecular Pathology releases survey findings and recommendations to improve implementation of European Union’s In Vitro Diagnostic Regulation

Feb. 22, 2024
Clinical laboratories require additional resources to understand complex compliance requirements, reduce workforce burdens, and ensure patient access to vital diagnostic testing procedures.

The Association for Molecular Pathology (AMP) released the results of its Impacts of the European Union (EU) In Vitro Diagnostic Regulation (IVDR) Survey. 

The anonymous survey was created and administered to molecular diagnostics professionals around the world to determine current levels of understanding, assess broad implications, and identify future trends related to the new regulation. The survey results are being used to help inform AMP’s clinical practice and advocacy programs with the shifting regulatory landscape worldwide.

AMP’s 35-question survey evaluated many important aspects of the IVDR, including laboratory demographics, day-to-day operations, implementation readiness, the Conformité Européene (CE) certification process, financial repercussions, and patient access. Feedback was collected from both AMP members and non-members from March 30, 2023 – April 28, 2023. Priority was given to laboratories directly impacted by the new IVDR and located within the European Union and the United Kingdom, but the survey was made available globally. Overall, the results showed a general sense of frustration and concern about the IVDR implementation process with the majority of laboratories seeking further instruction and education from the European Commission and their respective notified bodies, along with additional funding from payors dedicated to properly reimburse diagnostic testing.

Based on the common themes found in results from the survey, AMP made the following recommendations:

  1. Molecular diagnostic professionals should partner with laboratories and the National Competent Authorities (NCAs) to reduce administrative and other resource burdens while substantially increasing a more thorough understanding of the new IVDR requirements.
  1. Healthcare system authorities, insurance companies, national health systems, and other payers should allocate additional funding dedicated to properly reimburse diagnostic testing developed to comply with the IVDR. This recommendation was first made by the European Hematology Association. AMP agrees additional funding will be critical for preserving rare disease diagnostics.
  1. The European Commission, European Medicine Agency, and NCAs should facilitate meetings between the clinical laboratory community and regulatory experts to better ensure that laboratories can meet the standards of the IVDR.
  1. The European Commission, European Medicine Agency, and NCAs should bolster existing online resources and provide additional educational materials and communications on their webpage to assist with streamlining the regulatory process.

AMP plans to conduct a follow-up survey in 2025 and again in 2028 after the IVDR has been fully implemented for three years to track laboratory progression throughout the IVDR process.

AMP release