In view of the complex requirements of the IVDR, the VDGH believes that the deadline for the approval of these products, which expires in May 2025, is not feasible. This development raises serious questions regarding the guarantee of safe and seamless healthcare in Germany and the EU.
The VDGH therefore expressly welcomes the initiative for a rapid legislative procedure to extend the IVDR deadline. "We are in a critical phase in which rapid action is essential," explains VDGH Managing Director Dr. Martin Walger. "Due to the lack of regulatory infrastructure and long processing times for the certification of diagnostics, which take 12 to 24 months on average, it is an enormous challenge for the industry to meet the deadlines. An extension is therefore not only appropriate, but crucial for maintaining security of supply."
The VDGH also emphasizes that the deadline extension is only one aspect of the solution. Around a third of products would not be transferred due to specific problems in the creation of the IVDR. In addition, innovations would not reach the European market at all or would be delayed. To the detriment of patients.
The VDGH therefore believes that a fundamental revision of the legal framework for the approval of diagnostics and medical devices is essential in order to maintain security of supply in the healthcare sector. A white paper has been developed together with the German Medical Technology Association (BVMed) for the further development of the IVDR and MDR.
