NEW YORK – The Association for Molecular Pathology on Tuesday released the results of its survey on the impact of the European Union's In Vitro Diagnostic Regulation program.
The IVDR regulations introduced uniform requirements for European labs, requiring institutions to justify the use of their homebrew tests while imposing rules to ensure their safety and performance. AMP's survey sought to determine current levels of understanding of the program, assess its broad implications, and identify future trends related to the new regulation, as well as inform recommendations for AMP members and other pathology professionals.
According to AMP, the results indicate a "general sense of frustration and concern about the IVDR implementation process." Most labs that responded want 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, the association said.
The 35-question survey was administered to both AMP members and nonmembers in late March and April 2023, and asked about laboratory demographics and day-to-day operations, as well as about IVDR implementation readiness, the CE-certification process, financial repercussions, and patient access.
Among other results, the survey found that more than 40 percent of participants, including non-EU participants, feel that IVDR implementation has impacted their daily laboratory activities.
About 30 percent of respondents said that the IVDR implementation resulted in changes being made to their laboratory or testing practices.
AMP asked these survey participants to provide additional details and reported that respondents generally expressed apprehensions about the IVDR, and particularly cited a lack of guidance, ambiguous instructions for proper implementation, and increased overhead costs as concerns.
Based on the survey responses, AMP derived a set of four recommendations. First, it says molecular diagnostic professionals should partner with their National Competent Authorities (NCAs) to reduce administrative and other resource burdens and improve understanding of the new IVDR requirements.
Secondly, it says healthcare system authorities, insurance companies, national health systems, and other payors should fund efforts to ensure proper reimbursement under the IVDR, a proposal previously made by the European Hematology Association.
In addition, AMP called on the EC, European Medicines Agency, and NCAs to sponsor meetings between the clinical laboratory community and regulatory experts to help ensure labs can meet the new standards.
Finally, the organization wants those same groups to improve existing online resources and provide additional educational materials and communications on their webpages to assist with streamlining the regulatory process.
AMP President Maria Arcila said in a statement that the organization will continue to review and analyze the results of the survey.
"The IVDR is very complex and the new compliance requirements are placing a significant burden on clinical laboratories around the world. Given the current workforce shortage, laboratories will find it even more challenging to recruit and retain professionals in this specialized area of medicine," she added.
AMP also plans to conduct a follow-up survey in 2025 and again in 2028 after the IVDR has been fully implemented for three years.