• MDCG 2019-15:
  Guidance for class I products 
  
• MDCG 2019-14:
  Explanatory note on MDR codes
  
• MDCG 2019-13:
  Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
  
• MDCG 2019-12: 
  Designating authority's final assessment form: Key information (EN)

• MDCG 2019-11: 
  Guidance on Qualification and Classification of Software 

• MDCG 2019-10: 
  Application of transitional provisions concerning validity of certificates issued in accordance to

• MDCG 2019-9: 
  Summary of safety and clinical performance

• MDCG 2019-8: 
  Guidance document implant card  Art. 18

• MDCG 2019-7:  
  Guidance on Article 15 "PRRC"

• MDCG 2019-6v2:
  Questions and answers: Requirements relating to notified bodies
  

• MDCG 2019-5: 
  Registration of legacy devices in EUDAMED

• MDCG 2019-4: 
  Timelines for registration of device data elements in EUDAMED

• MDCG 2019-3: 
  Interpretation of Art. 54(2)b

• MDCG 2019-2: 
  Guidance on application of UDI rules to device-part of products

• MDCG 2019-1: 
  Guiding principles for issuing entities rules on basic UDI-DI 

The entire LIST OF GUIDANCE DOCUMENTS published by the European Commission can be found on the "DOCS ROOM".

The EU-Commission plans to use the Italian CND for the technical coding of medical devices for entry into the EUDAMED database as well as for further aspects e.g. for the sampling of the technical documentation.

The CND nomenclature will be further aligned with the existing GMDN nomenclature in order to reach further harmonization.

2021-05-26 (UDI Carrier on label) and

2023-05-26 (Direct marking for reusables)

• Class III products
• All Implantables

2023-05-26 (UDI Carrier on label) and

2025-05-26 (Direct marking for reusables)

• Class IIa products
• Class IIb products

2025-05-26 (UDI Carrier on label) and

2027-05-26 (Direct marking for reusables)

• Class I products