The official full implementation of the EU CE MDR regulation has comprehensively improved the market access threshold for global medical devices. For Chinese foreign trade enterprises engaged in Wound Care Supplies export, the new regulation accelerates industry elimination and industrial upgrading, promoting the transformation of Chinese medical consumable exports from low-price homogenization to high-quality compliant brand export.
The MDR regulation puts forward stricter requirements on product safety assessment, production quality system, clinical data verification and product labeling information. A large number of small and medium-sized factories with incomplete qualifications and non-standard production have been blocked from the EU market, while formal manufacturers with complete ISO13485 systems and complete certification qualifications have gained greater market space. Hypoallergenic, sterile and environmentally friendly wound care products have become the mainstream demand in the European market.
At present, more and more Chinese medical consumable enterprises are actively upgrading their production systems and product formulas to meet EU high-standard requirements. The industry has formed a good development trend of focusing on quality, compliance and technological innovation instead of low-price competition. In the future, compliant and high-quality Chinese medical devices will further occupy the European high-end market.