Your legal manufacturer for substance-based medical devices under the MDR
We assume manufacturer responsibility in accordance with Regulation (EU) 2017/745. From formulation development and technical documentation through to post-market surveillance, we support you throughout the entire process. Your brand and sales remain entirely in your hands.
The product concept is in place, but you lack the in-house capacity to create and maintain the technical documentation over the long term.
Changing requirements for private-label models
The MDR sets clear requirements for placing medical devices on the market under your own name. This requires a manufacturer to assume regulatory responsibility.
A clear separation between production and manufacturer responsibility
The contract manufacturer handles production, but not the regulatory manufacturer responsibility or the associated obligations, such as vigilance and post-market surveillance.
That’s exactly what Nutrin is here for.
We assume manufacturer responsibility in accordance with Regulation (EU) 2017/745 and support your medical device from development and technical documentation through to post-market surveillance.
