Theme EUDAMED Target Audience Manufacturers Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 Article 123(3) d) and e) Article 34(3) Article 29(4) Annex VI, part A section 2 Annex VI, part B IVDR (EU) 2017/746 Article 113 (3) a) et f) Article...
Theme Consultation procedure within the framework of clinical evaluation Target Audience Manufacturers, Notified Bodies Products Concerned - Class III implantable MD - Active Class IIb MD intended to deliver/remove a drug to/from the body...
Theme UDI – Combination products Target Audience Manufacturers Products Concerned Combination products : - devices incorporating, as an integral part, a substance which, used separately, would be considered a drug - devices intended for the...
Theme Basic UDI-DI Target Audience UDI Issuing entities Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 IVDR (EU) 2017/746 Documents mentioned This guide provides some clarification on the format of the basic UDI-DI. The basic UDI-DI...
Theme Certificates Target audience Notified Bodies (NB) Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 58(1) IVDR (EU) 2017/746 Article 53(1) Documents mentioned This guide provides additional information on the content of...
Theme EUDAMED – UDI database Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 28(3) Annex VI part C section 5.10 Article 33(1a) Recitals 43-46 IVDR (EU) 2017/746 Article 25(3) Annex VI part C section 5.10...
Theme Obligations of persons referred to in Article 16 Target audience Persons referred to in Article 16 Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 16 IVDR (EU) 2017/746 Article 16 Documents mentioned This guide provides...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
