Theme UDI – MD software Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Annex VI Part C IVDR (EU) 2017/746 Annex VI Part C Documents mentioned MDCG 2018-1 This guide provides additional information on the...
Theme UDI – Systems and procedure pack Target audience Persons referred to in Article 22 (Systems and procedure pack producer) Products concerned MD Regulatory references MDR (EU) 2017/745 Article 29(2) Annex VI Part B Documents mentioned This guide provides...
Theme UDI – Systems and procedure pack Target audience Persons referred to in Article 22 (Systems and procedure pack producer) Products concerned MD Regulatory references MDR (EU) 2017/745 Article 22 Article 29(2) Annex VI Part C points 3.7 and 6.3.1 Documents...
Theme European MD nomenclature (EMDN) Target audience All actors Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 26 IVDR (EU) 2017/746 Article 23 Documents mentioned The purpose of this guide is to clarify the criteria and...
Theme Basic UDI and UDI-DI Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Chapter III Annex VI IVDR (EU) 2017/746 Chapter III Annex VI Documents mentioned UDIWG 2018-1 European Commission : Q/A about UDI ...
• The update of the list of harmonized standards under the 3 Directives is planned for the end of 2020. • A new standardization request to CEN / CENELEC for harmonized standards under the Regulations is expected in the 1st quarter of 2021. • ...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
