“Recommendations for a strong health industry in Europe”
We recommend active integration of industry and the EU member state in the remaining period before the date of application of the MDR and IVDR in order to avoid any negative impact on the SMEs of the health industry and bottlenecks in the supply of medical products. Pragmatic steps for implementing the new regulations should be taken so that industry can make comprehensive preparations for the new regulations. This requires speedier state notification procedures for the certification bodies and substantially longer transitional periods. Central recommendations: ▪
In order for industry, in particular SMEs, to be able to fully prepare for the new provisions of the EU medical devices regulations, there is a need for longer transitional periods and faster state notification procedures for the notified bodies.
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We recommend the active integration of industry and the EU member states in the remaining period up to the date of application of the EU medical devices regulation in order to avoid negative effects on the health industry and bottlenecks in the delivery and supply of medical products.
4. Strengthening interdepartmental cooperation The health industry is a highly regulated and complex branch which is affected by many areas of public policy. Governments should devise their health policy targets on the basis of a holistic approach (health in all policies) and expand them into all policy areas. A sustainable Europe can only be successful if industry policy can be harmonized with social, digital and ecological objectives. In line with this approach, health aspects should be integrated into all publicly funded programmes. A universal and non-discriminatory access to health care should be achieved (universal health coverage) by means of a cross-thematic, interdisciplinary and intersectoral consideration of all health aspects (such as the One Health approach) in conjunction with the adequate funding of health systems. This concerns all areas of patient care, ranging from prevention and diagnostics via treatment and rehabilitation up to aftercare. In future we will continue to need a sustainable research and innovation policy which supports academic excellence, inventiveness and entrepreneurial courage. This will entail the strategic interlocking of the policy areas of industry, research and science, health, digitization and environment. Against this background the health industry recommends a greater degree of an interdepartmental policy strategy at the European level. So far we see little or no progress in the increased coordination that was announced between the various directorates general of (DGs) the European Commission. An innovation-friendly environment goes beyond a strict “silo mentality” and requires the coordination of several departments. The
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