The IVDR places extensive requirements on the marketing of laboratory diagnostic products and has already led to significant delays in the market launch of essential tests. "We see the extension of the transition periods as a necessary measure. However, far-reaching changes are needed to reduce those regulatory burdens that offer no safety benefits for users and patients," explains Dr. Martin Walger, Managing Director of the VDGH.
The VDGH therefore emphasizes the urgency of a comprehensive revision of the existing legal framework, which is supported by the evaluation of the IVDR by the EU Commission. The results of this evaluation must be incorporated into legislation as quickly as possible in order to safeguard patient care in the long term. In cooperation with BVMed - German Medical Technology Association, the VDGH has published a white paper on this topic, which highlights the need for a fundamental reform of the IVDR and offers concrete proposals for solutions.
New reporting obligations and EUDAMED
New requirements for mandatory reporting in the event of supply interruptions and the early use of EUDAMED are further elements of the amendment that has now been adopted. Here too, the measures should remain limited to what is necessary and avoid redundancies with national requirements.
Challenges at national level: the upcoming laboratory reform in the EBM
The sector is also facing challenges at national level. The planned changes to the reimbursement of laboratory tests harbor the risk that the importance and value of diagnostics will be underestimated. Dr. Martin Walger warns: "The underestimation of our industry's services is evidence of a false understanding of its essential role in healthcare. In order not to jeopardize the quality and availability of diagnostic tests, the VDGH is calling for a fundamental revision of the reform plans.
