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. The AIMDD was super­seded by Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) on May 26, 2021. Com­pli­ance infor­ma­tion below is pro­vid­ed for infor­ma­tion purposes.

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!

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

• Our Article”Most Impor­tant Changes – Reg­u­la­tion (EU) 2017/745 on Med­ical Devices (MDR)
• Our Com­plete Library Sec­tion with var­i­ous top­ics regard­ing MDR/IVDR
• Our page regard­ing Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR)