The European Federation of Laboratory Medicine (EFLM) supports the amendment to Article 5.5 of the In Vitro Diagnostic Medical Device Regulation (IVDR) proposed by the EU Commission. The current version burdens medical laboratories with excessive bureaucracy and hinders the development and availability of important diagnostics for rare and special diseases. This is the result of a positioning by the professional society dated April 9, 2026. DGKL Vice President Prof. Thomas Streichert was also involved in the paper.

The EFLM particularly welcomes the planned facilitations: the obligation for laboratories to prove that no comparable CE-marked product is available on the market is to be dropped. In addition, in-house tests will be allowed to be transmitted between facilities in the future if this serves patient protection or public health. Central laboratories that manufacture and use tests exclusively for clinical trials are to be explicitly included in the scope of the exemption.

According to the EFLM, the current strict interpretation of Article 5.5 leads to significant shortages of innovative diagnostics that the industry does not offer for economic reasons. Up to 50 percent of the biomarker portfolios in laboratories could consist of such in-house tests. The strict documentation and justification requirements hampered the care of patients with rare diseases and delayed the introduction of precision medicine procedures.

The European professional society emphasizes that the proposed changes do not endanger patient safety. Existing quality management systems in accordance with ISO 15189 as well as risk-based vigilance and regulatory monitoring were retained. The EFLM calls on the European Parliament and the Council to adopt the reform swiftly. This is the only way to remove unnecessary hurdles, ensure security of supply and maintain the innovative capacity of diagnostic medicine in the European Union.

Editor: X-Press Journalistenbüro GbR

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