On May 21, 2025, Rui Enni, together with DNV and Zhongjian Huatongwei, held a special seminar on "Challenges and Opportunities of Active Medical Aesthetics Products under MDR Regulations" at Shenzhen Xili (Huatongwei Laboratory).
During the meeting, Mr. Wang Hailong, the founder of Rui En Ni, brought the clinical trial design points and case sharing of MDR Annex XVI products to many students.
The product definition of MDR Annex XVI is: products for unexpected medical purposes; The products listed as examples in this appendix are classified as non regulatory products under MDD, so this type of product needs to undergo clinical trials to verify its safety and effectiveness under MDR.
After the meeting, Mr. Wang Hailong provided detailed answers to many students' questions about the clinical trial of Annex XVI type products, and received high praise from many students!
