The VDGH is therefore calling on politicians to make prompt improvements. In particular, more capacity must be created for notified bodies in order to support the certification of all IVDs and speed up lengthy certification procedures.
VDGH Chairman Ulrich Schmid explains: "Over the past five years, our companies have put a lot of effort and energy into implementing the requirements. However, many parts of the necessary regulatory infrastructure are still missing before the regulation comes into force."
Schmid points out that the industry is doing everything it can to ensure that diagnostic tests remain available for medical laboratories, doctors, hospitals and patients. Although great progress has already been made in implementing the new legal framework and additional transitional periods of up to five years have been granted, the incomplete IVDR infrastructure poses risks for nationwide care on the proven scale. Until these challenges are resolved, the new IVD regulation is not a reliable way to certify laboratory tests.
Together with the German Medical Technology Association (BVMed), the VDGH has presented an "Immediate Action Program IVDR and MDR". In this program, the associations outline solutions that the diagnostics and medical devices industry believes should be implemented as a matter of urgency. In addition to expanding the capacity of notified bodies and creating EU reference laboratories, efficient use of the existing resources of the certification system is also urgently required. This requires prioritization so that not only existing products but also innovations are quickly available for patient care. This is important in order to ensure that laboratory diagnostics, in particular for threatening and communicable diseases, remain guaranteed under the new legal framework.
Background
The IVDR completely rewrites the regulatory requirements. Greater emphasis will be placed on notified bodies, which will have to assess more than 80 percent of all IVDs in future. In addition, there will be a new risk classification system, EU reference laboratories for high-risk devices, updated requirements for clinical evidence, a new post-market system, a new database for greater transparency (EUDAMED) and a system for the unique identification of devices that facilitates traceability in the supply chain.
You can find the "Immediate action program IVDR and MDR" here: Positions - VDGH - Verband der Diagnostica-Industrie e.V.
