Regulation (EU) 2017/745 – also known as the Medical Devices Regulation (MDR) has been adopted on May 25, 2017 and will replace the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). There is a transition period of 3 years making the Regulation fully applicable on May 26, 2020. There are massive changes compared to the MDD confronting manufacturers with numerous challenges.

Our services:

• Technical files reserving, updating and submitting as per CA requirements;
• Register products to fulfil the obligations of notification as per EU directives and regulations via DIMDI 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 relevants;
• Issue “Free Sales Certificate” via EU CA.