Your questions about
our medical devices.

Vitrobio remains the legal manufacturer. Its name and address appear on the packaging. Your company markets the product under its own brand and appears as the distributor.

Several formulations are available for some indications. Product selection depends on your project, markets and existing distribution agreements. Our team will explain the options suited to your request.

Exclusivity reserves marketing of a defined formulation in an agreed territory to one distributor. Semi-exclusivity allows Vitrobio to appoint a second partner for that formulation under another brand. The scope, duration and associated commitments are specified in the contract.

Minimum manufacturing quantities and annual volumes must be confirmed with our team for the selected product and packaging.

We support our partners with the documentation needed to market the relevant products. Our regulatory team works with yours to clarify procedures and responsibilities for the target country. Registration requirements and documents vary by market and are reviewed as part of your project.

Our notified body for the relevant medical devices is GMED.

Our quality management system is certified to ISO 13485 by GMED. This certification covers the quality system applicable to medical devices.

Our marketed medical devices are certified under European Regulation (EU) 2017/745, also known as MDR. Projects still in development are identified separately on the site and should not be confused with products already available. Our team will clarify each product's regulatory status for your market.

We manufacture our medical devices in Issoire, France. For your project, our team confirms available capacity, lead times and the manufacturing schedule according to the product, packaging and expected volumes.

Our private-label offering is based on formulations developed and evaluated by Vitrobio. It does not include creating a new formulation at a distributor's request. We help you select available products and market them under your brand.

Our commercial basis is ex works (EXW): the distributor arranges transport. Logistics and product-specific storage and transport conditions are agreed with our team before ordering.

Our PolymR technology combines film-forming glycerol with polymers selected for the agents and mediators involved in the relevant indication. Composition varies by product. Product-specific information is available on its page and in its instructions for use.

Glycerol attracts fluids through osmosis and helps maintain a hydrated environment. On its own, it is rapidly diluted. Combining it with natural polymers stabilises the formulation: this is film-forming glycerol. Film persistence depends on the product, application site and conditions of use; no single duration applies to the entire range.

Some polymers are selected for their association with glycerol and their contribution to the film's resistance to dilution. Others are chosen for their affinity with the agents and mediators targeted by the formulation. They retain these elements within the film. The combination depends on the indication.

The formulation acts on the treated surface: it attracts fluids, contributes to cleansing, forms a protective interface and retains relevant agents in the film. Polymers do not need to seek their targets inside cells or tissues. This principle does not remove the need to assess tolerability or follow each product's precautions.

Vitrobio's patents cover its technology and formulations. Marketing a Vitrobio device under your brand does not transfer manufacturing rights or rights to exploit the technology. Rights granted to your company are specified in your contract with Vitrobio.

Our medical devices are not presented as sterile products. They are manufactured within our ISO 13485 quality system. Storage conditions, precautions for use and information after opening must be checked in each product's instructions for use.