The implementation of the EU Medical Devices Regulation (EU) 2017/745 presents many companies with significant challenges. The regulatory requirements are particularly demanding, especially in the field of medical lubricants, but also for other healthcare products.

This entails a great deal of effort for retail chains, brands and manufacturers. Without in-depth expertise in medical device compliance within the EU, market entry is virtually impossible. Specialists such as Livondo provide companies with expert support – from development through to MDR-compliant manufacturing of lubricants and complementary cosmetics.

What is the MDR 2017/745 and why does it also apply to medical lubricants, amongst other things?

The MDR 2017/745 aims to make medical devices even safer throughout their entire lifecycle. It was introduced in response to serious quality deficiencies. The previous directives dated back to the 1990s and therefore no longer provided adequate consumer protection. Since its full implementation, the MDR (Medical Device Regulation) has governed the requirements for medical devices within the EU.

Lubricants, particularly those intended for medical use, also fall under this regulation due to their application on mucous membranes. A lubricant must comply with the MDR (EU) 2017/745. This is precisely why it is important to be able to draw on specialist knowledge – specialist knowledge that Livondo possesses. After all, as a certified supplier, we have been developing such products for years.

The MDR requirements for medical devices entail significantly stricter standards. The numerous regulatory hurdles include detailed technical documentation as well as the clinical evaluation of the substances used. Risk analysis and risk management must be ensured. And responsibility does not end once the product is placed on the market: UDI (Unique Device Identification) for product traceability, continuous market surveillance and a reporting obligation in the event of incidents are also part of the requirements of MDR 2017/745.

Livondo takes the pressure off you when it comes to the requirements of the MDR 2017/745.

Livondo handles all the prescribed processes as part of its full-service manufacturing for its customers. This is why major European retail chains that sell their own brands have long been among its clients. For all customers, working with the Bonn-based specialists means enhanced product safety and reduced organisational effort.

As a full-service manufacturer, Livondo offers structured solutions for private-label clients – from the product concept through to MDR compliance.

For clients, healthcare and cosmetic products from Livondo mean:

• No time-consuming product development
• Lower risks through assumption of product responsibility
• No need for complex in-house approval procedures
• No need for extensive in-house documentation
• High-quality products and enhanced brand image

Without an experienced partner, implementing the MDR 2017/745 can quickly become a hurdle.

Companies wishing to have medical lubricants or healthcare products manufactured can rely on the following from us:

• a wide range of formulations
• the assurance that lubricants and cosmetics are produced exclusively in Germany
• indemnity for our products

The numerous brands and retail chains already working with us particularly appreciate being able to focus entirely on sales and marketing.

Lubricants and cosmetics: high demand for MDR-compliant products

The market for medical lubricants and healthcare products is growing rapidly. Consumers are becoming increasingly discerning as health awareness rises. More than ever, they are looking for proven safety, clearly declared ingredients and prefer certified products.

Livondo began early on to develop and manufacture innovative, high-quality products that combine medical applications with natural ingredients. That is why, with a partner like Livondo, the implementation of the MDR 2017/745 is not an obstacle, but a driver of growth.

With extensive experience in medical device compliance within the EU, the company offers a one-stop solution. Please feel free to contact us.

Der Beitrag Lubricants under the Medical Devices Regulation 2017/745 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.

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.

LIVONDO offers the manufacture of private label medical devices in accordance with EU Regulation 2017/745 (MDR). Consulting, development, production, documentation, shipping and exemption from liability can be realised with our 360° services – with appropriate labelling.

Our aim is to always offer you first-class advice for your private label products. We cover all the necessary services to fulfil your specific requirements. With our expertise, we guide you through the entire process and combine our know-how of the EU Medical Device Regulation 2017/745 (MDR) and the Cosmetics Regulation (CIR) with our in-depth market knowledge. Thanks to our extensive experience in product development, product management and marketing, we provide you with optimal support for all relevant issues.

At LIVONDO, comprehensive service is not an additional offer, but a matter of course.
We can realise your individual product ideas from a minimum order quantity of 10,000 units. Our certified recipes, diverse production options and generous capacities enable rapid realisation and maximum flexibility.

Livondo – your partner for consulting, development and production

Der Beitrag All-round support erschien zuerst auf Livondo.

In the first few months of life, your baby explores the world primarily through touch. The rich vujo Frischling Baby Body Lotion provides intensive care for your baby’s sensitive skin and helps to soothe dry areas of skin. It is quickly absorbed and leaves the skin feeling pleasantly soft.

vujo Frischling Baby Body Lotion contains moisturising aloe vera, precious almond oil and nourishing shea butter; all ingredients naturally provide optimum protection and care in organic quality.

Recommended by dermatologist Prof Dr med Szeimies and easy to use:
‘Apply a sufficient amount to your hand and gently spread the lotion onto baby’s skin in circular movements. vujo Frischling Baby Body Lotion is specially developed for sensitive baby skin, is PH skin neutral and helps to form the skin’s natural protective barrier. vujo Frischling is suitable for daily use on all skin types: normal, sensitive and also on skin prone to neurodermatitis.’

Der Beitrag vujo Frischling Baby Body Lotion erschien zuerst auf Livondo.