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!

Der Beitrag Certified German Quality – For Maximum Safety erschien zuerst auf Livondo.

Medical lubricants and their strengths

Intimacy and pain are usually not wanted, but are often the case with vaginal dryness. Vaginal dryness can have many causes, including hormonal changes during the menopause, while breastfeeding or when taking the pill. Stress or other individual factors can also have a negative impact on natural moisture production. In such cases, medical lubricants provide the necessary moisture to enable pain-free and pleasant sexual intercourse.

And even with sufficient moisture, many couples appreciate the additional lubrication, as it reduces friction and provides a more intense sensation. LIVONDO offers a wide selection of high-quality medical lubricants that meet precisely these requirements.

Lubricants and condoms – what you should bear in mind

The use of condoms in combination with medical lubricants requires special attention. Lubricants based on oil or grease, such as baby oil or Vaseline, can attack latex materials and thus damage condoms, i.e. rob them of their functionality. This may allow an unwanted pregnancy or the transmission of pathogens.

You are on the safe side with water-based medical lubricants from LIVONDO . These products have been specially developed to be compatible with barrier methods such as condoms, diaphragms or cervical caps. So you can enjoy intimacy without compromising on safety and protection.

The correct use of medical lubricants

The application of medical lubricants is very simple: Apply a small amount of lubricant directly to the desired area – such as the vagina, penis or sex toy. For beginners in particular, it is advisable to test the right amount in advance.

Desire to have children and contraception

Medical lubricants do not protect against pregnancy or sexually transmitted diseases. A condom is essential for protection against sexually transmitted diseases. If there is a desire to have children, it is advisable to choose a medical lubricant that does not affect the natural pH value of the vagina. Thanks to LIVONDO ‘s innovative product range, you are guaranteed to find the right medical lubricant for your individual needs.

LIVONDO develops quality lubricants for various leading companies in this segment.

Der Beitrag LIVONDO – Medical lubricants erschien zuerst auf Livondo.

Since August 2016, LIVONDO has been certified in accordance with DIN EN ISO 13485:2012, which confirms our expertise in the ‘manufacture and distribution of water- and silicone-based medical lubricants’.

Our products bear the CE mark and are offered as class I and IIa medical devices. Customers benefit from tried and tested, certified formulations that are ready for immediate use. Major brands and leading retailers in the condom sector in Europe rely on the quality of LIVONDO GmbH.

Der Beitrag Certified quality management erschien zuerst auf Livondo.