Lubricants under the Medical Devices Regulation 2017/745

Thoroughly familiar with the Medical Devices Regulation 2017/745. Livondo supports major retail brands.

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.