23 Nov 2020 | MDCG
Theme Notified Bodies Target Audience Notified Bodies Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 Annex VII IVDR (EU) 2017/746 Annex VII Documents mentioned NBOG 2017-2 In this document, the MDCG proposes in the form of questions and...
23 Nov 2020 | MDCG
Theme EUDAMED – Legacy Devices Target Audience Manufacturers Products Concerned Legacy Devices (MD, AIMD and IVD) Regulatory reference MDR (EU) 2017/745 Article 120(3) IVDR (EU) 2017/746 Article 110(3) Documents mentioned This guide deals with the...
23 Nov 2020 | MDCG
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...
23 Nov 2020 | MDCG
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...
23 Nov 2020 | MDCG
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...
