10 Jun 2022 | All the News, MDCG, MDCG
Theme Clinical trials using diagnostic tests Target Audience Manufacturers and clinical trials sponsors Products concerned IVD & medicines Documents mentioned Regulation (EU) 2017/746 Regulation (EU) No 536/2014 Directive 98/79/EC This guide provides...
10 Jun 2022 | All the News, MDCG, MDCG
Theme Summary of safety and performance (SSP) Target Audience Manufacturer Products concerned Class C and D IVD Documents mentioned Regulation (EU) 2017/746 This guidance presents the model of the summary of safety and performance (SSP). This one must be established...
10 Jun 2022 | All the News, MDCG, MDCG
Theme Transitional provisions Target Audience Manufacturers, Authorised representatives, Importers, Distributors, Notified Bodies Products concerned IVD Documents mentioned IVDR (EU) 2017/746 IVDR – Article 110 Blue Guide MDCG 2019-5 MDCG 2021-13 rev.1 This...