The timing of the implementation of the revision – the proposed three-year transition period - is simply too short for compliance. Unlike the medical device sector, IVD manufacturers will have to contend with the implementation of new requirements for clinical evidence. This entails new clinical studies being carried out, a whole new classification system, and a complete overhaul of most of the key aspects of the legislation. Australia is implementing a system modeled on the same principles as the proposed regulation and their experience shows that a transition period of less than five years is likely to lead to significant disruptions in the IVD sector, not only for manufacturers but also for authorities, and ultimately patients.
“Failing to account for the time it takes to produce clinical evidence will be a disadvantage for both the innovative in vitro diagnostic industry, and access to safe diagnostic technologies within the EU,” said Serge Bernasconi, Chief Executive Officer of EDMA.
While now discussions move on to the Council, the IVD industry is already working to ensure that compliance with the new requirements will have the least possible impact on access to essential diagnostics. Both patients and industry stand to benefit from a system, which not only ensures the safety of IVD devices but also allows for a simple, though rigorous, access to the market for new technologies.
European Diagnostic Manufacturers Association (EDMA) is an international, non-profit organisation representing the interests of the medical in vitro diagnostics (IVD) industry in Europe. Its mission is to promote the value of IVDs in delivering sustainable and effective public health systems, and provide technical, regulatory and market research information to its members. The European IVD industry is a market worth around €11 billion. Driven by research and development, 95% of the industry is comprised of small and medium size enterprises and approximately 1 billion euros per year is reinvested in R&D. EDMA is a member of MedTech Europe, an alliance of European medical technology industry associations. For more information, visit www.edma-ivd.eu.