Publications : All the News

  Theme Specific additional procedures Target audience Notified Bodies, Manufacturers Products concerned ·       Devices containing a substance which may be considered a medicinal product and which has action ancillary to that of the device ·       Devices...

Theme Designation and monitoring of Notified Bodies (NB) Target audience Authority responsible for Notified Bodies Products concerned MD, AIMD Documents mentioned Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No...

Theme Clinical investigation Target audience Sponsors (Manufacturer, Legal Representative or Contact Person) Products concerned Investigational MD Regulatory references MDR (EU) 2017/745 Article 80(2)   This document defines the modalities for reporting Serious...

Theme Ventilators – Covid-19 Target Audience Manufacturers, Notified Bodies Product concerned MD : Ventilators and their accessories Regulatory reference MDR (EU) 2017/745 Article 59   MDD 93/42/EEC Article 11(13) Documents mentioned EN ISO/IEC 80601-2-12:2011 +...

Theme Post-market Clinical Follow-up Target audience Manufacturers, Notified bodies Products concerned MD (including Legacy Devices)* Regulatory references MDR (EU) 2017/745 Article 61 Annex XIV – Part B     EN – This guide provides a detailed evaluation...

Theme Post-Market Clinical Follow-up Target audience Manufacturers, Notified bodies Product concerned MD (including Legacy Devices)* Regulatory references MDR (EU) 2017/745 Article 61 Annex XIV – Part B     EN - This guide provides a detailed template for...

Theme Clinical Evaluation – clinical evidence Target audience Manufacturer, Notified bodies Product concerned MD CE-marked  under Directives Regulatory reference MDR (EU) 2017/745 Article 61 Annex XIV – Part A Documents mentioned MEDDEV 2.7/1  rev. 4 (2016) : Clinical...

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: Guide...

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)  ...

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...