Intelligent outsourcing –
Manufacturer responsibility for
medical and cosmetic products

LIVONDO – Liability exemption and regulatory security

LIVONDO offers you the opportunity to effectively outsource the complex manufacturer responsibility for medical and cosmetic products. Our quality management system is certified according to DIN EN ISO 13485:2016 and our production processes meet the requirements of both the Medical Devices Regulation (MDR) and the European Cosmetics Regulation (KVO).

Let us provide you with comprehensive information in a personal meeting.

Exemption from liability for medical devices

Personal lubricants for intimate use fall under the Medical Device Regulation (MDR) and must fulfil strict regulatory requirements in order to bear the CE mark. As a quasi-manufacturer that sells a product under its own brand, you would not be allowed to market such products without the appropriate certifications and would also have to assume full liability under the German Product Liability Act (ProdHaftG).

LIVONDO offers you an intelligent outsourcing model that allows you to leave the manufacturer responsibility entirely with us. If we are labelled as the responsible manufacturer on the product packaging and a corresponding agreement has been made, we assume compliance with all regulatory requirements. This relieves you of the manufacturer’s obligations and the associated liability, allowing you to concentrate on marketing your products.

Do you want to launch personal lubricants on the market and minimise your liability risk? Get in touch with us.

Liability exemption for cosmetic products

We also offer a liability exemption model for cosmetic products. Our manufacturing processes are certified according to GMP (Good Manufacturing Practice). This ensures that all products meet the legal requirements of the KVO for the European market. Here, too, we take full responsibility for compliance with the KVO.

Let our team of experts advise and support you.

Your advantages with LIVONDO

  • certified processes: Our manufacturing processes meet the highest quality standards.
  • regulatory security: We take responsibility for compliance with the MDR and European KVO.
  • focus on your core business: You are relieved of manufacturer obligations and can concentrate on your brand.

With LIVONDO you have a reliable partner who not only ensures the manufacture of medical and cosmetic products, but also ensures compliance with all regulatory requirements. This means you can concentrate on the essential aspects of your business without worry.

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