23 Nov 2020 | MDCG
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...
19 Nov 2020 | MDCG
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...
19 Nov 2020 | MDCG
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...
19 Nov 2020 | MDCG
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...
19 Nov 2020 | MDCG
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...
