The European market has huge consumption potential for personal care products, especially personal lubricants, but it also sets strict entry standards. The CE mark of the product is the basic requirement for it to comply with relevant EU regulations (such as the Medical Device Regulation MDR), proving that the product's safety and performance have reached the specified level.
For brand owners hoping to sell personal lubricant products in Europe, choosing an OEM/ODM partner whose products and production systems are in compliance with CE standards is the crucial first step. Pingchuang Medical Group is just such a professional manufacturer that can help brands smoothly enter and establish themselves in the European market.
Obtaining the CE mark is not an easy task; it requires manufacturers to establish and maintain a quality management system that complies with EU regulations, usually based on ISO 13485. Manufacturers must conduct risk assessments for their products to ensure that all aspects such as design, raw materials, production processes, labeling, and instructions meet the requirements of relevant directives or regulations. For products like personal lubricants that may be considered medical devices, biological compatibility tests (such as cytotoxicity, irritation, and sensitization) are also required, and detailed technical documents (Technical File) must be prepared for review. Only after passing the audit by a designated notified body (for certain categories of medical devices) can the product be affixed with the CE mark.
Pingchuang Medical deeply understands the entry barriers of the European market and considers compliance with CE standards as an important part of its quality system. The company has several personal lubricant products that have successfully obtained CE certification, which means that these products have passed the test of EU standards in terms of design, safety, performance, and technical documentation. Brand owners who choose to cooperate with Pingchuang Medical can directly use these certified products for private label production, thereby greatly simplifying the process of entering the European market, saving time and certification costs.
The support for CE certification comes from Pingchuang Medical's strong production and quality management system. Its 16,000 square meter production base and 3,000 square meter Class 10,000 clean room provide a physical guarantee for the production of high-purity personal lubricants. Strict adherence to GMP regulations and the quality management system certified by ISO 13485 ensures the standardization of the production process and the stability of product quality, which is consistent with the requirements of the CE certification for the quality system.
In terms of raw material selection, Pingchuang Medical always uses high-quality, reliable medical-grade raw materials. These materials are selected and have good biocompatibility, meeting the high safety requirements of the European market. Theperfect internal laboratory can carry out necessary physical and chemical performance tests and support biocompatibility assessments, providing data support for the CE compliance of the products.
The professional team of Pingchuang Medical is familiar with the requirements of the EU Medical Device Regulation (MDR) and can provide customers with consulting services on CE certification. For customers who need customized development based on the Pingchuang platform and apply for new CE certification, Pingchuang Medical can also provide support in areas such as technical documentation preparation and test coordination to help customers overcome regulatory barriers. This professional service capability is an extremely valuable resource for brand owners looking to expand into the European market.
Collaborating with Pingchuang Medical to produce personal lubricants that meet CE standards, customers can not only obtain products that meet the requirements for market access in Europe but also enjoy other advantages of Pingchuang Medical. Over 2000 mature formulas provide a rich foundation for innovation, diverse packaging options meet the needs of different channels and brand positioning, and one-stop services (design, sampling, qualification authorization) improve project efficiency. The extensive experience in exporting products to 76 countries around the world also proves its ability to serve international customers.
For brand owners aiming to enter the European market, choosing an OEM/ODM partner whose products and systems both meet CE standards is the key to success. With its certified products, internationally compliant production conditions, strict quality management, professional regulatory support, and comprehensive services, Pingchuang Medical is undoubtedly the ideal choice for producing high-quality export-grade personal lubricants to help brands set sail in Europe.
