Dec­la­ra­tion of Conformity

As part of the CE Mark­ing process and the cor­re­spond­ing con­for­mi­ty assess­ment pro­ce­dure, man­u­fac­tur­ers must draw up a Dec­la­ra­tion of Con­for­mi­ty. In sim­ple terms, the Dec­la­ra­tion of Con­for­mi­ty is the manufacturer’s for­mal dec­la­ra­tion that the devices list­ed on the doc­u­ment are in con­for­mance with the med­ical devices Direc­tives or Reg­u­la­tions respectively.

It is a high­ly offi­cial and legal­ly bind­ing doc­u­ment that should only be signed by a senior officer. 

The Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR) stip­u­late cer­tain con­tents that must be includ­ed, e.g.:

• Man­u­fac­tur­er and EU Autho­rized Rep­re­sen­ta­tive details includ­ing SRN
• Basic UDI-DI
• Prod­uct details
• Risk class and rule(s)
• Noti­fied Body and Noti­fied Body cer­tifi­cate details 
• Con­for­mi­ty assess­ment procedure
• For­mal state­ments and contents

Do you need assis­tance in set­ting up your Dec­la­ra­tion of Con­for­mi­ty? mdi Europa can assist with valu­able insights and may also pro­vide a tem­plate. Please con­tact us for fur­ther information.

To receive fur­ther infor­ma­tion on Con­for­mi­ty Assess­ment Pro­ce­dures please use links below

• Check our exten­sive down­load section
• View our graph­ics of Con­for­mi­ty Assess­ment Procedures
• Vis­it our Sup­port­ive Infor­ma­tion Sec­tion on MDR / IVDR
• Browse our use­ful link section
• Get in con­tact with our team