AIMDD – Active Implantable Medical Devices Directive

The Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)  gives manufacturers the opportunity to develop their own compliance program. We guide you through the entire process and assist to optimize your compliance program to meet your product specifications and business needs.

AIMDD Compliance Process

  1. Appoint your European Authorized Representative
    → Ask for our quotation!
  2. Identify all EU Directives/Regulations applicable to your product (such as MDR, WEEE, EMC etc.)
    → We will assist!
  3. Identify the applicable harmonized standards for your product 
    → We will provide a list!
  4. Check your device against the Essential Requirements (annex I)
    → We will provide a checklist!
  5. Select and perform the Conformity Assessment Procedure applicable to your product 
    → We will guide you through!
  6. Prepare a Technical File and (if applicable) implement a Quality Management System 
    → We will assist!
  7. Select a Notified Body and sign your Declaration of Conformity 
    → We will provide lists and forms!