The Biomedical Alliance in Europe (Biomed Alliance) is calling on European policymakers to integrate regulatory science into the framework governing medical devices and in vitro diagnostics (IVDs). This follows the publication of a Viewpoint article in The Lancet Regional Health – Europe, which demonstrates how the European Union’s current system remains hindered by a regulatory structure originally designed to harmonise standards for industrial products, rather than to safeguard health products.
Authored by leading clinicians and scientific experts on behalf of 35 medical professional associations, the publication emphasizes that the EU’s regulatory reliance on private “notified bodies”—which act as quasi-regulators in a competitive marketplace—has created a fragmented system lacking necessary transparency and scientific rigor.
This approach has resulted in unpredictable, protracted conformity assessments, driving manufacturers to withdraw essential products from the European market, including established technologies and vital medical devices for children and rare diseases. To ensure equitable access to safe, effective, and innovative technologies, the Biomed Alliance advocates for a renewed focus on integrating ‘regulatory science’ into European governing institutions.
Key priorities for regulatory reform are to:
- Centralise and resource scientific expertise: The EU must substantially invest in boosting medical and scientific capacity within a central coordinating unit. The mandate of the European Medicines Agency (EMA) should be expanded to assume a stronger coordinating function among national authorities for multi-national clinical investigations and post-market surveillance.
- Prevent the ‘equivalence’ loophole for high-risk technologies: High-risk implantable devices should not be approved solely on claims of equivalence to existing devices. This resulted in multiple cases of avoidable patient harm in the past, and these difficult lessons should not be unlearned. High-risk implantable devices require rigorous clinical investigations, to demonstrate both safety and efficacy.
- Protect diagnostic innovation and precision medicine: The current In Vitro Diagnostic Regulation (IVDR) heavily restricts laboratory-developed tests (In-House IVDs), which account for over 50% of available IVD tests and are critical for precision medicine and orphan indications. The EU must relax restrictions on sharing In-House IVDs between healthcare institutions and abolish IVDR Article 5.5 d, which currently stifles academic innovation in favour of manufacturers.
- Support the establishment of regulatory science as a medical subspecialty: Clinicians, statisticians, epidemiologists, and engineers must actively collaborate with regulators to develop shared standards, and ‘regulatory science’ must be cultivated as a dedicated subspecialty within every medical field.
Professor Alan G. Fraser, first author of the Viewpoint and Scientific Coordinator of the CORE-MD project: “The European regulatory system for medical devices was developed to serve an internal common market, not to evaluate complex medical interventions. We must replace this outdated industrial framework with a transparent, evidence-based approach. It is unacceptable for high-risk therapeutic implants to enter the market without published evidence of clinical benefit, and transparent demonstration of a positive benefit-risk balance. True regulatory reform requires establishing scientific standards to protect patient safety without imposing disproportionate bureaucracy.”
Professor Elizabeth Macintyre, co-author and past-President of the Biomedical Alliance in Europe: “Innovation in personalized medicine, particularly within genetics and precision diagnostics, is being compromised. The current legislation restricts our laboratories from developing and utilising the very in-house tests that are essential for advanced patient care. We need a centralised, well-resourced regulatory infrastructure driven by medical experts to ensure that regulatory policies support—rather than obstruct—critical diagnostic innovation and fair access to life-saving technologies across Europe.”
Additional Resources
To read the Viewpoint in The Lancet Regional Health – Europe, visit: Fraser A, Byrne R, Dequeker E et al. Empowering regulatory science for medical devices in Europe, The Lancet Regional Health – Europe, 2026; 71 https://doi.org/10.1016/j.lanepe.2026.101876.
To read our latest position paper on the revision of the MDR and IVDR, please visit: Biomedical Alliance in Europe. (2026, June 25). Healthcare professionals share views as negotiations on MDR & IVDR revision continue. https://www.biomedeurope.org/news/healthcare-professionals-share-views-as-negotiations-on-mdr-ivdr-revision-continue/
