MedNet handles CE certification for the taps and manifolds from global market leader Elcam Medical and is therefore able to offer them non-sterile with the CE mark. "MedNet is well positioned in the regulatory area because it has access to an established workflow and corresponding resources. Certification by MedNet gives us the opportunity to offer our joint customers in Europe maximum regulatory support," says Amir Bohadana, Sales Executive Director at Elcam Medical, explaining the decision to hand over the regulatory part to MedNet. MedNet has been distributing Elcam components in the European market for more than 30 years. In addition to distribution, MedNet has also specialized in the registration of globally manufactured medical devices for the European market for over 20 years and launched its own product line in 2013. With the CE marking of the non-sterile component, MedNet is responding to the needs of medical device manufacturers across Europe who are facing increasingly stringent regulatory requirements. Each component of a product or set now requires a technical file, which increases the regulatory burden and raises the hurdles for innovation. "Smaller companies lack the staying power it takes to get through the registration process. The provision of CE certificates for individual non-sterile components facilitates the creation of the product file and significantly reduces the time required for market launch," explains Ole Stein, Managing Director at MedNet. In addition to time and financial savings, this also increases the planning security for new developments and sets. For kit packers who are dependent on the CE of their components in accordance with Article 12 MDD (Article 22 MDR), the purchase of the non-sterile variant saves the additional unpacking/packaging effort compared to the packaged, sterile medical device and avoids the problem of a second sterilization in the set.In addition to the Elcam stopcocks and stopcock banks, MedNet offers numerous other non-sterile CE-marked components in the field of fluid management as well as for angiography and interventional cardiology/radiology.