The IVDR was introduced to create more safety and transparency in healthcare. However, experience to date shows that many of the extensive requirements are bureaucratically excessive without increasing patient safety, and the regulatory framework causes significant problems for patient care. The industry has done its homework and created the conditions for safe care, yet the current regulations continue to hinder access to urgently needed diagnostic tests for patients, especially in the areas for rare diseases.
"The IVDR places extensive requirements on the marketing of laboratory diagnostics and has led to considerable delays in the market launch of important products," explains Dr. Martin Walger, Managing Director of the VDGH. "Even established and safe products are at risk of becoming unavailable and no longer available to patients." Small and medium-sized enterprises (SMEs) in particular are disadvantaged by the complex regulatory procedures. "A third of all class D products are at risk of disappearing from the market, including vital tests such as HIV tests and blood donation safety diagnostics. This poses a serious threat to patient safety," Walger continued.
The VDGH is therefore campaigning for a fundamental reform of the IVDR. Together with the German Medical Technology Association (BVMed), a white paper has been drawn up that contains concrete proposals for solutions, including the introduction of an accelerated approval procedure ("fast-track") for innovative products and the abolition of the costly five-year recertification process. "We need more transparency, predictability and efficiency in order to strengthen Europe's competitiveness and at the same time ensure patient care in the long term," demands Walger.
The European Commission is now called upon to take concrete steps. The VDGH expects the new Health Commissioner to act immediately and tackle the problems of the IVDR in order to prevent impending bottlenecks in healthcare. Patients and companies in Europe must no longer suffer from unnecessary bureaucracy and inefficient processes.
Further information and the joint white paper from the VDGH and BVMed can be found online at www.vdgh.de/whitepaper.
