The Med­ical Devices Direc­tive 93/42/EEC (MDD) gave man­u­fac­tur­ers the oppor­tu­ni­ty to devel­op their own com­pli­ance pro­gram. The MDD was super­seded by Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) on May 26, 2021. Com­pli­ance infor­ma­tion below is pro­vid­ed for infor­ma­tion purposes.

MDD Com­pli­ance Process

  1. Appoint your Euro­pean Autho­rized Rep­re­sen­ta­tive
    → Ask for our quotation!
  2. Iden­ti­fy all EU Directives/Regulations applic­a­ble to your prod­uct (such as MDD, 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 (for Class IIa and high­er) and sign your Dec­la­ra­tion of Con­for­mi­ty 
    → We will pro­vide lists and forms!

If you are inter­est­ed in top­ics regard­ing MDD you might also find informative