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...
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)...
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 mentioned...
Theme Cybersecurity Target Audience Manufacturer Products Concerned MD that include programmable electronic systems and software that are MD in their own right Regulatory reference MDR (EU) 2017/745 Annex I IVDR (EU) 2017/746 Annex I Documents mentioned - ...
Theme Marketing Target Audience Manufacturers, Person designated in article 16(1) of the MDR Products Concerned Class I MD Regulatory reference MDR (EU) 2017/745 Article 16(1) Documents mentioned This document provides a summary of the regulatory obligations...
Theme Designation code of Notified Bodies Target Audience Notified Bodies, Designating authorities, Manufacturers Products Concerned MD Regulatory reference Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding...
Theme Conformity Assessment of the Technical Documentation : sampling Target Audience Manufacturers, Notified Bodies Products Concerned Classes IIa and IIb non implantable MD Classes B and C IVD Regulatory reference MDR (EU) 2017/745 Article 52(4) et 52(6) Annex IX...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
