With the full implementation of the EU Medical Device Regulation (MDR), the threshold for exporting water based lubricant to Europe has significantly increased. The old MDD certificates are gradually becoming invalid, and the new MDR regulations pose unprecedented challenges for product safety evaluation, clinical data, and post-market surveillance. For brands aiming to deeply penetrate the European market, understanding and adapting to the MDR regulations has become the only rule for survival in this high-profit market.
The core of the new MDR regulations lies in the redefinition of product classification and the tightening of the regulatory chain. Under the MDR framework, the compliance review cycle for water based lubricant has been significantly extended, and certification costs have soared to the million-level range. The new regulations require manufacturers to have more comprehensive risk management reports and stricter biological evaluation data. This means that small OEMs lacking R&D capabilities will be completely driven out of the competition. Brands that fail to promptly switch to suppliers with MDR compliance capabilities will face the catastrophic risk of being unable to legally market in Europe or even being forcibly removed from all platforms.
Under the new MDR regulations, the standardization of labels and instructions has been elevated to a new level. Products must have a unique UDI identifier and be traceable in the EU medical device database. Although these high compliance standards increase initial investment, they present an excellent opportunity for strong brands to eliminate competitors. By partnering with manufacturers who have forward-looking strategies, hold MDR compliance certificates, or are upgrading their systems, brands can share technological benefits, establish high competitive barriers in the European market, and secure long-term stable market shares.
Pingchuang Medical closely follows international regulatory developments, holding EU CE and ISO13485 certifications, and has established a comprehensive quality system to comply with the new MDR regulations. Leveraging over 2,000 mature formulations and GMP-standard production lines, we enable clients to share compliance certification without incurring million-dollar costs. Pingchuang Medical supports multiple parameter customizations and free packaging design to help brands quickly launch export projects. With medical-grade production quality assurance, we assist products in achieving compliant market entry in Europe and 76 other countries worldwide.
