Services: Release from Liability
Outsourcing manufacturer responsibility through us
As a manufacturer of medical devices, our quality management system is certified according to DIN EN ISO 13485:2016. Due to their area of application on the mucous membrane, lubricants for intimate intercourse in the EU are covered by the Medical Device Regulation VO (EU) 2017/745 MDR (Medical Device Regulation). As a distributor, we must meet high regulatory requirements and quality standards. All our lubricants are therefore allowed to be labelled with the CE mark (approval mark according to EU directives).
By identifying ourselves as the responsible manufacturer on the products, we exempt you from the legal requirements of medical devices and liability. This allows you to concentrate fully on marketing your products.
Your advantage of having a tested and certified partner who not only supplies safe premium products, but also offers an intelligent outsourcing model regarding manufacturing responsibility.
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