GERMANY UP CLOSE: IVDs Industry Says Reg Changes Must Be Proportionate And Relevant
This article was originally published in Clinica
Executive Summary
Germany’s IVDs industry is the largest in Europe, with a local market valued at €2.2bn (reagents and equipment/systems) in 2014-15. It accounts for 20% of the wider European market, but the overwhelmingly SMEs-based industry is nervous about the changes that the proposed EU IVDR will bring, clearly worried that an inappropriately heavy regulatory hand will damage the sector’s ability to innovate