24 Nov 2020 | MDCG
Theme Clinical Evaluation – Equivalence Target Audience Manufacturers Products concerned MD and Products of Annex XVI Regulatory references MDR (EU) 2017/745 Article 61 Annex XIV PART A (3) Documents mentioned MEDDEV 2.7/1 rev. 4 (2016) : Clinical evaluation:...
24 Nov 2020 | MDCG
Theme COVID-19 – Audit Target Audience Notified Bodies, Manufacturers, Subcontractors Products concerned MD, IVD Documents mentioned IAF MD 4 (Mandatory Document for the Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes)...
24 Nov 2020 | MDCG
Theme Transitional provisions – significant changes Target Audience Manufacturers, Notified Bodies Product concerned Medical Devices that are covered by a valid certificate issued in accordance with a Directive and that continues to be placed on the market after the...
24 Nov 2020 | MDCG
Theme Transitional provisions Target Audience Manufacturers Products Concerned Class I MD (excluding Im, Is) in accordance with the Directive 93/42/CEE that change class in accordance with the Regulation Regulatory reference MDR (EU) 2017/745 Article 120(3) et 120(4)...
24 Nov 2020 | MDCG
Theme Clinical evaluation – Software Target Audience Manufacturers Products concerned SaMD and Software as a part of a MD Regulatory reference MDR (EU) 2017/745 Article 61 Article 2(51) IVDR (EU) 2017/746 Article 56 Article 2(36) Documents...
