In-vitro diagnostic medical devices
Additional Information
Our Strength:
Umedwings has a professional team for MDR , we are familiar with EU laws and regulations, and built good communication with Netherlands CA as well as CAs of other members of EU. Umedwings keeps good relationship with relevant European chambers of commerce, medical associations and certify bodies. Our Shenzhen office was established to provide efficiency to customers in China.
Our Services:
-Technical files reserving, updating and submitting as per CA requirements;
-Register products to fulfill the obligations of notification as per EU directives and regulations via Farmatec or EUDAMED;
-Collect and transfer the products’ information in EU market;
-Transfer information and assist to handle products’ complaints in EU market;
-Transfer product’ information of clinical investigation or performance evaluation in EU market;
-Transfer information and assist to launch vigilance system process for product’ accidents happened in EU market;
-Contact with EU CA or other relevant;
-Issue “Certificate of Marketability” via EU CA.
Related Regulations
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT