The In Vit­ro-Diag­nos­tic Med­ical Devices Direc­tive 98/79/EC (IVDD) offered mul­ti­ple routes to com­pli­ance – depend­ing on the spec­i­fi­ca­tions and intend­ed pur­pose of use of your prod­uct. The IVDD was super­seded by Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) on May 26, 2022. Com­pli­ance infor­ma­tion below is pro­vid­ed for infor­ma­tion purposes.

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!

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