Medical Device

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.

-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.
 

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT  

For Umedwings to be your European Authorized Representative,

the manufacturer have to complete the following steps:

1- The product compliance must be ensured

2- The product must be classified according MDR rules.

3- A Notified Body must be involved (for products other than class I) and the technical file including the Declaration of Conformity must be prepared

4- The CE mark must be affixed and labeling has been completed

5- The Authorized Representative must be included in the manufacturer’s product liability insurance

6- An agreement between manufacturer and Umedwings has to be signed