▪️Clinical data requirements for EU CE certification:

Dr. Andrew Gibson gave a detailed interpretation of the clinical data requirements under the EU Medical Device Regulation (MDR) at the meeting, including key contents such as clinical evaluation and data adequacy, clinical data sources, and pre-market and post-market data requirements. Dr. Gibson also analyzed the generation logic and compliance path of clinical evidence under the MDR, emphasizing that manufacturers need to focus on risk management, build a dynamic chain of evidence (from preclinical to PMCF), and achieve scientific grading and integration of evidence through the MDCG guidelines, ultimately achieving closed-loop verification of safety and performance claims.

▪️Can Chinese clinical trial data be used for CE certification?

Dr. Leslie Hammermueller gave an overview of the EU MDR clinical research requirements during the meeting and explored in depth the connection between the ISO 14155 standard and the EU MDR, helping to understand how to conduct clinical research globally and ensure data transferability.

She pointed out at the meeting that data transferability needs to be verified through systematic literature analysis and demonstration, covering multiple dimensions such as laws and regulations, population, and medical system, to ensure that non-EU data can effectively support CE certification applications.

▪️Why is obtaining CE certification so important for Chinese medical device companies?

Johnson Yang shared at the meeting the importance of Chinese medical device companies obtaining CE certification, and combined with actual cases, analyzed how CE certification can help Chinese companies enter the global market and enhance brand competitiveness.

He pointed out at the meeting that Chinese medical device companies are rising rapidly through technology upgrades and global layout (such as mergers and acquisitions, technology transfer), and CE certification has become a key springboard for opening up high-end markets and building international competitiveness, but they need to overcome the long-term challenges of regulatory adaptation and resource investment.

▪️Question and answer session

The seminar specially invited Martin Chen, founder of LINKS CRO, and Dr. Echo Liu, senior director of quality and regulatory affairs at Vantive Healthcare, to discuss the challenges and opportunities of medical device globalization. Participants raised questions during the Q&A session and received real-time answers from experts.