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MedNet assumes responsibility for the regulatory support for CE certification of the stopcocks and manifolds from the world market leader Elcam Medical and is now able to
offer them CE marked in non sterile version.
“In the regulatory area, MedNet is well positioned because it has an established workflow and access to the appropriate resources. The certification by MedNet gives us the opportunity to offer our mutual customers in Europe the maximum regulatory support,” explains Amir Bohadana, Sales Executive Director at Elcam Medical, in the decision to outsource the regulatory support to MedNet.
MedNet has sold Elcam components on the European market for more than 30 years. In addition to sales, MedNet has been supporting the registration of international medical devices for the European market for over 20 years and has also launched its own product line in 2013.
With the CE mark on the non sterile component, MedNet is responding to the needs of medical device manufacturers all over Europe, who are faced with higher regulatory requirements coming into effect. Every component of a device or set now requires a technical file, which increases the regulatory effort and the hurdles for innovations. “Small companies don't have the staying power until the registration is completed. Providing CE certificates for individual non-sterile components simplifies the preparation of the product file and significantly reduces the time required for a market launch”, explains Ole Stein, Managing Director at MedNet.
With the purchase of the non sterile CE marked components, medical device manufacturers save the regulatory effort. In addition to time and financial savings, it also increases planning reliability for new developments and sets.
For Custom Procedure Tray providers who in accordance with Article 12 MDD / Article 22 MDR depend on a CE mark for theirs components, the purchase of the non-sterile version saves the additional unpacking / packaging effort and bypasses the problem of a second sterilization in the set compared to the packaged, sterile medical device.
In addition to the Elcam stopcocks and manifolds, MedNet offers various non sterile CE marked components from the field of fluid management as well as for angiography and interventional cardiology / radiology.