IVDD – In Vitro Diagnostic Medical Devices Directive

The In Vitro-Diagnostic Medical Devices Directive 98/79/EC (IVDD) offers multiple routes to compliance – depending on the specifications and intended purpose of use of your product. mdi Europa guides you through the entire process and assists to optimize your compliance program to meet your product specifications and business needs.

IVDD Compliance Process

  1. Appoint your European Authorized Representative
    → Ask for our quotation!
  2. Identify all EU Directives/Regulations applicable to your product (such as environmental regulations etc.)
    → We will assist!
  3. Identify the applicable harmonized standards for your product 
    → We will provide a list!
  4. Check your device against the General Safety and Performance 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 (if applicable) and sign your Declaration of Conformity 
    → We will provide lists and forms!