2018-10

The European Commission has issued 5 new MDCG endorsed documents:

• MDCG 2018-3   Guidance on UDI for systems and procedure packs
• MDCG 2018-4   Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
• MDCG 2018-5   UDI Assignment to Medical Device Software
• MDCG 2018-6   Clarifications of UDI related responsibilities in relation to Article 16
• MDCG 2018-7   Provisional considerations regarding language issues associated with the UDI database

The guidances can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en