Presentation on new European in-vitro diagnostics regulation held in Stuttgart
At the invitation of BIOPRO, a representative from BIO Deutschland’s office informed the attendees of the BIOPRO-organised event in Stuttgart about the new regulations on medical devices and in-vitro diagnostics (IVD). The legal framework for in-vitro diagnostics will change significantly when the EU’s new IVD regulation goes into effect. Besides a completely new classification system, manufacturers must prepare themselves for stricter conformity requirements and monitoring rules as well as additional changes. It is expected that the EU’s new IVD regulation will enter into force as early as the first quarter of 2017. The new requirements must be met within a five-year transition period in order to gain CE certification for products.