"It's good that Europe is getting moving. The IVDR in its current form is not fit for the future. The evaluation is an important step towards a structural reform," explains Dr. Martin Walger, Managing Director of the VDGH. "The common goal must be a regulatory framework that is practical, innovation-friendly and patient-oriented."
Last year, the VDGH and BVMed presented a comprehensive white paper on the further development of the legal framework for medical devices and diagnostics. In it, the associations call for, among other things
- the introduction of accelerated approval procedures (fast track) for innovations and niche products,
- the abolition of the five-year re-certification cycle in favor of a risk-based, data-driven system,
- greater centralization of responsibilities at European level.
"If Europe is serious about its claim to remain a center of innovation, then a structural revision of the IVDR is needed quickly," says Walger. "Germany is the leading location for laboratory diagnostics. The sector creates jobs in this country, secures prosperity and is indispensable for modern patient care in the EU. All of this is at stake."
Dr. Sascha Wettmarshausen, regulatory affairs expert at the VDGH, emphasizes: "We have been calling for an evidence- and practice-based further development of the IVDR for a long time. The consultation that has now been completed must not remain without consequences. Its results must lead to concrete, tailor-made amendments to the law - in the interests of companies and, above all, patients. Small and medium-sized companies in particular suffer disproportionately from the bureaucratic burden that hinders research and development. Yet it is often these companies that produce important innovations and also serve niches - with crucial importance for healthcare. Their disappearance has fatal consequences for patient safety."
The VDGH appeals to the European Commission to translate the results of the consultation into an immediate package of measures and concrete legislative proposals. The structured dialog with industry, science and the healthcare sector must be consistently continued.
