Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 1 of 13 
 The CND Nomenclature  
‘Classificazione Nazionale Dispositivi medici’  
 
 
Table of Contents  
1. Background and General Principles  ................................ ................................ ................................ ...... 2 
2. The CND structure  ................................ ................................ ................................ ................................ .. 4 
Anatomic Categories – by anatomical area of use:  ................................ ................................ ...................  6 
Functional Categories – by intended use or clinical method:  ................................ ................................ .... 6 
Special Categories – by other criteria:  ................................ ................................ ................................ .......  6 
Groups: the second hierarchical level  ................................ ................................ ................................ ........  7 
Type: the third hierarchical level (expands into several levels of detail (1°, 2°, 3°, 4° and 5°))  ...........  7 
3. External links  ................................ ................................ ................................ ................................ ...........  8 
 
 
The purpose of this document is to provide information regarding the basic principles and the 
structure of the Italian  “Classificazione Nazionale Dispositivi medici” (CND) . In March 2019, an d 
according to the criteri a set out by the Medical Device  Coordination Group1 (MDCG) , the CND 
was selected as the basis for the future European M edical Device Nomenclature  (EMDN ). The 
EMDN  will support the functi oning of EUDAMED  as stated by the MDCG and in accordance with 
Articles 23 of Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746.  
 
 
  
                                                           
1 (MDCG 2018 -2) – Future EU medical device nomenclature: Description of requirements  Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 2 of 13 
 1. Background and General Principles2 
In 2005, the Italian Ministry of Health set out that the  CND would be the  official Italian medical 
device  classification and  nomenclature. Since then, t he CND has been  implemented not only in  Italy, 
but also  in Portugal and Greece.  
About 15.000 manufacturers3 from various countries have used the CND for the registration of 
medical devices and in vitro  diagnostic medical devices in the Italian database. The distribution of 
manufacturers of medical devices and in vitro  diagnostic  medical  devices per countr y is reported 
below in Figure 1. 
 
 
   Fig. 1 Distribution of manufacturers of medical devices per countr y 
 
The CND nomenclature  is one of the tools used in the  governance of the medical device sector  and 
is characteri sed by its refined and hierarchical structure . It aims to support the improvement of 
patient safety and the quality of health systems by enabling information to be communicated in a 
standard ised manner . 
 
Updates and maintenance of CND:  
                                                           
2 The principles and rules presented thereafter are the ones historically established/followed when building the CND nomenclature u p 
to the last update in 2018. This is without prejudice to the new rules that will govern the EMDN  which will be  established by th e 
MDCG.  
3 Source NSIS: data updated on 10 August 2019  31,6%  
15,2%  
10,2%  9,8%  
3,9%  3,6%  2,7%  2,5%  2,0%  18,5%  
0,0%5,0%10,0%15,0%20,0%25,0%30,0%35,0%Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 3 of 13 
 The construction of the CND , its subsequent updates and maintenance have been  based  on three  
fundamental principles.  
A) Participative approach:  
For the update and maintenance of a qualitative nomenclature, highly differentiated and 
qualified expertise is required. As the  medical device sector is acknowledged  for its 
heterogeneity and complex ity, a broad participation of all stakeholders (economic operators and 
healthcare professional from NHS - at all levels of its organisation ) is essential.   
 
B) Qualified validation of proposals :  
Nomenclature and Classification proposals are technically validated based on  assessment s of 
actual need . Factors taken into  consideration are: 
 other existing nomenclature and classification systems available at international level  
 consumption and expense information  
 assessment with sector experts from the different disciplines  
 
C)  Formal adoption and free public availability:  
The CND system , which represents the basis of the whole information system on medical 
devices is formally approved and thus constitutes an offici al reference, freely available to all 
stakeholders.  
 
More information on previous  updates of the CND up to 2018 can be found in Annex I of this 
document.  
 
The following pr oducts are currently not included in the CND : 
 Medicinal products  
 Cosmetics products  
 Human blood and its derivatives;  
 Organs, tissues and cells of human origin, products including human tissues and cells and 
products derived therefrom.  
 Organs, tissues and cells of animal origin except medical devices manufactured using 
animal devitalized tissues o r devitalized products derived from animal tissue.  
 Individual Protection Devices  Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 4 of 13 
 2. he CND structure   
The CND is characterised by its alphanumeric  structure that  is established  in a multi -level 
hierarchical tree . It clusters medical devices in  three main levels:  
 Category:  the first hierarchical level  
 Group:  the second hierarchical level  
 Type:  the third hierarchical level  (which  if necessary, expands into several levels of detail 
(1°, 2°, 3°, 4° e 5°))  
 
 
 
Each medical device is classified by an alphanumeric code consisting of a letter referring to the 
“Category”, a couple of numbers referring to the “Group” and a series of other couples of numbers 
referring to the “Type” (whose amount depends on the level o f detail) up to a maximum of 7 levels . 
 
 
Each level isidentified by:
•an alphanumeric code (max 13 digits )
A ## ## ## ## ## ##
Level 1: 
C ategoriesLevel 2: 
GroupsLevel from 3 to 7:
TypesMedical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 5 of 13 
 Categories:  the first hierarchical level  
The first hierarchical level of the CND is defined  as a “Category”.  There are 22 categories, each 
identif ied by a letter of the alphabet:  
 
Each “Category ” includes devices regulated under Directive 93/42/EEC, 90/385/EEC or 98/79/EC 
or following a dedicated prescription from reimbursement rules in Italy. These “categories” are used 
for the same specific apparatus, anatomical district or organ or as a replace ment of them 
(anatomical categories), or devices characterised by similar use, intended use or clinical m ethod 
(functional categories).  
Considering these criteria and the ramified tree structure with different detail level, the following 
Anatomic (8), Fun ctional (9) and Special (5) Categories have been defined:  
 
Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 6 of 13 
 Anatomic Categories – by anatomic al area of use:  
• B – HEMATOLOGY AND HEMOTRANSFUSION DEVICES  
• C – CARDIOCIRCULATORY DEVICES  
• F – DYALISIS DEVICES  
• G – GASTROINTESTINAL DEVICES  
• N – DEVICES FOR NERVOUS AND MEDULLAR SYSTEMS  
• Q – DENTAL, OPHTALMOLOGIC AND ENT DEVICES  
• R – RESPIRATORY SISTEM AND ANAESTHESIA DEVICES  
• U –UROGENITAL APPARATUS  DEVICES  
 
Functional Categories – by intended use or clinical method:   
• A –  DEVICES FOR ADMINISTRATION, COLLECTING AND PICKING  
• D – DISINFECTANTS, ANTISEPTICS AND P ROTEOLYTICS FOR MEDICAL 
DEVICES  (regulated by Italian Legislative Decree No. 46/97  and European Directive 
93/42/EEC ) 
• H – SUTURE DEVICES  
• K – ENDOTHERAPY AND ELECTROSURGICAL DEVICES  
• L – REUSABLE SURGICAL INSTRUMENT S 
• M – DEVICES FOR GENERIC AND SPECIALISTIC MEDICATION  
• S – STERILIZATION DEVICES  
• T – PROTECTION DEVICES AND INCONTINENCE AIDS ( regulated by Italian 
Legislative Decree No. 46/97  and European Directive 93/42/EEC ) 
• V – MEDICAL DEVICES - VARIOUS  
 
Special Categories – by other criteria : 
• J – ACTIVE -IMPLANTABLE DEVICES : MDs  regulated by Directive 385/90 EEC   
• P – IMPLANTABLE PROSTHETIC DEVICES AND OSTEOSYNTHESIS DEVICES : 
non-active implantable MDs  
• Y – SUPPORTS OR TECHNICAL AIDS FOR DISABLED PERSONS  
• W – IN VITRO DIAGNOSTIC DEVICES MDs regulated by Directive 98/79  EEC  
• Z – MEDICAL EQUIPMENT AND RELATED ACCESSORIES AND MATERIALS  
 Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 7 of 13 
 Groups : the second hierarchical level  
The second  hierarchical level s are  called “Group s”. There are 146 anatomical/functional Medical 
Devices Gr oups  4, which  represent the various differentiations that distinguish devices contained in 
the Categories. They are identified by two -digit nu mbers from 01 to 99 for each Category.  
Number “90” identifies the gr oups of devices having various characteristics that are not related to 
existing gro ups. Number “99”  “Altri – Others” is reserved to medical d evices that are not included 
in already existing Groups and will be categori sed in later updates.  
Type: the third hierarchical level (expands into several levels of detail (1°, 2°, 3°, 
4° and 5°)) 
The “Type” represents the third hierarchical level . If necessary, it expands into several level s of 
detail (1°, 2°, 3°, 4° and 5°). The group of every type includes medical devices characteri sed by a 
high affinity of use, intended use or s imilar clinical method. In case of doubt, the peculiar 
characteristics of the medical device under examination should be considered for a proper 
collocation or search proces s (i.e. the anatomic -functional characteristics and/or the intended use 
declared by the manufacture r). 
As explained, the term “ot hers” marked with the code “99 ”on the first detail level is suitable for 
devices not included i n existing types. The “99”  types will be submitted for later updates. Th e code 
reserved to the generic term “others” must be used by users only if it is not possible to classify the 
medical device in existing typologies .  This type is subject  to continuous checks and monitoring.  
Regarding accessories, e very accessory follows the CND classification code of the medical device 
that it is associated with , according to the intended use  given by the manufacturer . If an accessory 
can be used with multiple medical devices belonging to several group s, it must be placed  in the 
prevalent type.  
 
  
                                                           
4 Updated as of the Italian Ministerial Decree of 13 March 2018.  Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 8 of 13 
 3. External links  
 
For more information, please  consult the Italian Ministry website at: 
http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=328&area=dispositivi -
medici&menu=classificazione  
      
The fo llowing documents  may also be of use : 
 National Classification of Medical Devices (CND) - as modified by Ministerial Decree 
13.03.2018 ( PDF format)  
 National Classification of Medical Devices (CND) - as modified by Ministerial Decree 
13.03.2018 (XLSX format)  
 English translation of National Classification of Medical Devices Codes (as modified by 
Minister ial Decree 13.03.2018 -pdf, format).  
 English translation of National Classification of Medical Devices Codes (as modified by 
Ministerial Decree 13.03.2018 -XLSX format).  
 Search code and description of the CND  
 Search in alphabetical order  
 
  Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 9 of 13 
 Annex I – CND updates up to 2018  
The periodical updating process of the CND was schematically subdivided into four main phases:  
 
 Phase 1:  
Collection of proposals  This phase is open to all stakeholders who submit proposals for 
the definition of new classifications or for the revision of existing 
ones.  
 Phase 2:  
Preliminary technical 
evaluation and elaboration 
of the proposal.  The MoH MD Technical Team (MDTT) analyses th e collected 
proposals, the existing systems and the contents of the medical 
devices database to identify elements useful for classification.  
 Phase 3:  
 “Widespread validation” 
of the proposal.  The proposal is formally evaluated in three steps:  
A) the regional levels of the NHS involving clinical professionals 
in technical sessions  
B) Technical Health Committee - medical devices section of the 
Ministry of Health  
C) State - Regions Conference   
 Phase 4:  
Formal adoption of the 
proposal  Finally, the proposal is approved by formal MoH act and 
published on the Italian Official journal as well as the website of 
the Italian MoH  
 
 
Most of the inputs adopted for updating purposes are listed below:  
 The analysis of the terminal typologies "90" and "99":  
Implemented and consolidated, it originates from the analysis of information within the Italian 
databank and consider s data from  all the medical device s registered and classified in the CND 
terminal types with code " 90" ( - various) and "99" ( - other) of specific categories or groups 
identified. In fact, the classification system had already foreseen ab origine that medical devices 
that are not placed in a specific “typology” are classified in the generic typologies in dicated 
with the codes 90 and 99.  
 Manufacturer requests:  
When a manufacturer is unable to classify a medical device in an appropriate way inside the 
CND terminal level, a specific request for the introduction of a new CND class is required, with 
a communic ation to the MoH of a rationale and the technical characteristics and / or intended 
use that differentiate the device from the specific terminal classes already represented in the 
CND.  
 The analysis of CND coming from vigilance system:  Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 10 of 13 
 Market surveillance and the vigilance system are part of the institutional activities of the MOH. 
The lack of classificatory level can emerge in order to identify products that need particular 
attention for public health.   Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 11 of 13 
  The analysis of consumption by the NHS:  
The revision of the CND made through the processing of the consumption data of the 
Monitoring Database is based on identification of medical devices with great economic 
relevance or price variability.  
 The analysis coming from HTA Report s: 
Health Technology Assessment documents are periodically published by the Ministry of Health. 
These reports are considered when evaluating  the revision of the CND.  
The following principles were considered in the revision of the CND:  
 the number of levels in the CND structure can be inc reased up to a maximum of seven, by 
coherently applying the homogeneity of the classification rules and of the coding system 
defined for the first CND structure.  
 for the definition of a new CND branch the number of manufacturers manufacturing the medical 
devices that will be placed in the new typology of the CND should be more than 1;  
 significant characteristics of medical devices detected by NHS professionals should be 
evaluated  
 the proposal of relocation of medical devices placed in class 90 or 99 should  be consistent.  
 for the definition of a new CND branch significant differences of price between similar medical 
devices could be considered if necessary:  
 for the definition of a new CND branch an assessments related to the use of medical devices is 
conside red (quantity and number of users in NHS);  
 
For each update proposal of the CND, the information associated to the devices registered in the 
Italian database were analysed and, if necessary, the information detect ed by the “Consumption 
Monitoring Database” were processed.  
 
 
 
 
  Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 12 of 13 
 Annex II – CND VERSIONS  
Art. No. 57 of the Italian Law n° 289 of the 27 December 2002 stated the  requirement of the  
establishment of a Commission on Medical Devices (CUD) as a technical advisory board to the 
Ministry of H ealth. The CUD has the task of defining and updating the repertoire of medical 
devices and classifying all medical devices in specific classes and sub -classes.  
The CUD d efined the first version of the Classificazione Nazionale dei Dispositivi Medici (CND) 
on July 2005 (Italian Ministerial Decree of 22 Sept .2005). In Vitro  Diagnostic Medical Devices 
(regulated by European Directive No. 98/79 EEC and Italian Legislative De cree No. 332/2000) 
were not  included in the first version of the Classification , although they belong to a class of 
Medical Devices.  
The Italian Financial Law of 2006 (Law No. 266 of the year 2005, art. 1, par. 409) established that 
the CND has to be appr oved by a decree of the Minister of Health in agreement with the State -
Regions Conference.  
The CUD considered it appropriate to review and update the CND with the inclusion of in vitro  
diagnostic medical devices before proceeding with the State -Regions Con ference . Therefore,  on 20 
February 2007 , and after a revision of the classification, the Health Minister decreed  the approval of 
the Classificazione Nazionale dei Dispositivi Medici (CND) drawn up by the CUD. The 
classification refers to the medical device s regulated by Italian legislative decrees N°. 507/92, N°. 
46/97, N°. 332/2000 and subsequent amendments.  
In 28 March2013, the Italian D.P.R. n.44, replaced the Commission on Medical Devices (CUD) 
with the Technical Committee section F on medical devices.  
The Classification represented the first step towards the establishment of the Italian Repertoire of 
the Medical Devices.  
According to the art. N° 2 of The Italian Financial Law No. 266, the Technical Committee section F  
(previously CUD) , review the CND a nd make  the necessary changes and updates. Every update is 
approved by a Ministerial Decree:  
 
1. Decree of the Italian Ministry of Health (13 Mar 2008) regarding Modification and update of 
Classificazione Nazionale dei Dispositivi Medici (CND) published in th e Official Gazette - GU 
No. 125 of 29/05/2008. Links:  
http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_2_file.pdf   Medical Devices                January 2020  
DG Health and Food Safety  
Directorate Health systems, medical products and innovation  
Unit Medical Devices  
Page 13 of 13 
 www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_3_file.xls   
2. Decree of the Italian Ministry of Health (12 Feb 2010) regarding Modification and update  of 
Classificazione Nazionale dei Dispositivi Medici (CND) published in the Official Gazette - GU 
No.119 of 24/05/2010. Links:  
http://www.salute.gov.it/imgs/C_1 7_pagineAree_328_listaFile_itemName_5_file.pdf   
www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_7_file.xls   
3. Decree of the Italian Ministry of Heal th (7 Oct 2011) regarding Modification and update of 
Classificazione Nazionale dei Dispositivi Medici (CND) published in the Official Gazette - GU 
No.259 of 7/11/2011.Links:  
http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_9_file.pdf   
www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_10 _file.xls   
4. Decree of the Italian Ministry of Health (29 July 2013) regarding Modification and update of 
Classificazione Nazionale dei Dispositivi Medici (CND) published in the Official Gazette - GU 
No. 258 of 04/11/2013). Links:  
http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_16_file.pdf   
www.sa lute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_17_file.xlsx   
5.  Decree of the Italian Ministry of Health (8 J une 2016 ) regarding Modification and update of the 
Classificazione Nazionale dei Dispositivi Medici (CND )  published in the Official Gazette G.U. 
Serie Generale, n. 242 del 15/10/2016).  
6. Decree of the Italian Ministry of Health (13 march 2018) regarding Mod ification and update of 
the Classificazione Nazionale dei Dispositivi Medici (CND ) published in the Official Gazette 
G.U. Serie Generale, No. 116 del 21/05/2018). Links:  
http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_15_file.pdf   
www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_18_file.xlsx