EU Declaration of Conformity

The relevant fields in the EU Declaration of Conformity are indicated with the GS1 Data Source ID. Below is an explanation of the relevant fields. 

 

Attributes on EU Declaration of Conformity (DoC) 

GS1 Data Source ID 

BMS ID 

Explanation 

Tip 

Meaning of symbol and (code to be entered) 

243 

665 

Certification Agency 

Refers to the name of the organisation that issued the certification (notified body) 

3132 / 3131 

173 / 171 

Additional Trade Item Classification Code Value / Additional Trade Item Classification System Code 
 

Refers to the risk class of the device 
 
If the product is certified under the MDR or IVDR, use code 76 and one of the following values:  
EU_CLASS_I, EU_CLASS_IIA, EU_CLASS_IIB, EU_CLASS_III, EU_CLASS_A, EU_CLASS_B, EU_CLASS_C, EU_CLASS_D. 

  
If the product is certified under the MDD, rIMDD of IVDD, use code 85 and one of the following values:   

EU_CLASS_I, EU_CLASS_IIA, EU_CLASS_IIB, EU_CLASS_III, IVDD_ANNEX_II_LIST_A, IVDD_ANNEX_II_LIST_B, IVDD_DEVICES_SELF_TESTING, IVDD_GENERAL. 

1118 

1580 

Is Trade Item Implantable 

Indication of whether the product is implantable or not (TRUE or FALSE) 

3098 

 93 

Name manufacturer 

Legal manufacturer