The new EU Commission faces the major task of making the in-vitro diagnostics regulation fit for the future. The current legal framework not only jeopardizes the innovative strength of the industry, but also the security of care for patients in Europe," says Dr. Martin Walger, Managing Director of the VDGH. "We now need concrete measures to reduce bureaucratic hurdles and accelerate innovation processes."
The IVDR, which was originally intended to create more safety and transparency, is hindering market access for important diagnostics in its current form. Small and medium-sized enterprises (SMEs), which make up a large part of the diagnostics industry, are particularly affected. A third of all highly complex diagnostics are at risk of disappearing from the market - including vital tests such as HIV diagnostics and safety tests for blood donations.
Dr. Walger emphasized in his speech: "The extension of the transitional periods was a necessary measure, but it only treated the symptoms. The IVDR in its current form is neither sustainable nor predictable. That is why we need a fundamental reform that is geared towards the needs of the industry."
The VDGH therefore supports the efforts for a targeted reform of the IVDR, as proposed in the joint white paper with the German Medical Technology Association (BVMed). The core demands include
- Introduction of a fast-track approval procedure for innovations and products for rare diseases.
- Abolition of the five-year re-certification cycle in favor of a risk-based approach.
- Greater centralization of administrative functions under the management of a central institution such as the EMA in order to make processes more efficient.
Dr. Peter Liese, spokesperson for health of the EPP Group in the European Parliament, stated that the IVDR had overshot the mark by far. The Parliament's resolution of October 23 therefore logically calls for the reduction of unnecessary bureaucracy and a fundamental revision of the legal framework. At the initiative of France and Germany, the European Council is set to discuss a rapid package for administrative simplification at the beginning of December. Furthermore, concrete proposals for amending the IVDR and MDR are to be presented, including fast-track procedures for innovations, special regulations for orphan diagnostics and transparent and predictable procedures for notified bodies.
The participants at the VDGH conference emphasized the need to maintain Europe as a location for innovation. "The European diagnostics industry has the potential to set global standards - if the framework conditions are right," emphasized Ulrich Schmid, Chairman of the VDGH.
The VDGH appeals to the new EU Commission to prioritize these reforms and to work closely with industry, science and health authorities. The momentum created by the EU-wide discussion on the IVDR and the new political constellation must be used to strengthen Europe as a leading location for diagnostics.
