Do you manufacture an in vitro diagnostic medical device? If so, you will need a CE Mark certificate to market it in the EU. A CE certificate verifies that a product is safe and performs as intended. The regulation, (EU) 2017/746 (IVDR) Annex I, prescribes general safety and performance requirements for the design and verification of an in vitro diagnostic medical device product. SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements and get your product to market.