Update: Certification in accordance with Regulation (EU) 2017/745 (MDR)
The quality of medical devices directly affects their effectiveness and safety for all users. LIVONDO is aware of this special responsibility. As a certified manufacturer, we guarantee compliance with Regulation (EU) 2017/745 (MDR), the Medical Devices Implementation Act (MPDG), and the European Cosmetics Regulation (EC) No. 1223/2009. This is part of our commitment to full EU MDR compliance in every stage of production.
The audit, carried out in line with the strict requirements of a quality management system, was performed by ECM-Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH, accredited by the German Accreditation Body (DAkkS). This DAkkS accreditation confirms that the audit was conducted according to the highest internationally recognised standards – an additional mark of German quality medical products and trust for our customers and partners.
LIVONDO has been certified for establishing and implementing a professional quality management system in accordance with Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes (DIN EN ISO 13485:2021), within the scope of manufacture and distribution of medical lubricants. This standard places high demands on the design, development, manufacturing, delivery, and servicing of medical devices. Our consistent EU MDR compliance ensures that these processes meet all legal and quality requirements.
LIVONDO is a proven, reliable, and highly competent partner for certified health and personal care products. Since our founding three decades ago, we have been committed to producing safe and effective products of the highest standards. Cosmetic and medical gels as well as natural cosmetics are our core expertise.
We continuously develop innovative, high-quality product solutions for renowned international brand manufacturers and retail chains. As an owner-managed company, we are recognised for bringing innovations to market and for further improving existing products in the interests of our customers. Millions of safe, nourishing products are both proof of our quality and motivation for our ongoing commitment.
Regular Certifications – Essential for Body-Care Products
The Medical Device Regulation (MDR) harmonises existing specifications and requirements for medical device manufacturers in the European Union, with the aim of protecting patient health. In addition, the MDR defines clear specifications for the performance and transparency of various medical devices in their fields of application. At LIVONDO, we take this responsibility seriously every day.
Because of their intended use on mucous membranes, lubricants for intimate use fall under the Medical Device Regulation (EU) 2017/745 (MDR) in the EU. According to the MDR, they are classified as Class I medical devices or higher, depending on their composition and intended purpose. All LIVONDO lubricants are authorised to carry the CE mark – the official approval mark under EU directives. This means our customers benefit from CE-certified lubricants, certified medical devices (CE), and premium care products in accordance with Cosmetics Regulation (EC) No. 1223/2009.
In short: as a manufacturer and distributor of lubricants and care products such as creams, we consistently meet the highest regulatory requirements and quality standards while maintaining full EU MDR compliance.
Certified German Quality – Learn more about our certificates here!
