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...
Theme Designation of Notified Bodies Target Audience Notified Bodies and Conformity Assessment Bodies, Designating authority Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 and IVDR (EU) 2017/746 Documents mentioned NBOG 2017-3 NBOG...
Theme Software and apps qualification and classification Target Audience Manufacturers Products Concerned MD/IVD Software and apps Regulatory reference MDR (EU) 2017/745 and IVDR (EU) 2017/746 Annex VIII Documents mentioned IMDRF/SaMD WG/N12FINAL:2014 :...
Theme Transitional provisions Target Audience Manufacturers, Notified Bodies Products Concerned MD,AIMD Regulatory reference MDR (EU) 2017/745 Article 120 Documents mentioned CAMD FAQ – MDR Transitional provisions This guide addresses article 120 of the MD Regulation,...
Theme Summary of Safety and Clinical Performance (SSCP) Target Audience Manufacturers, Notified Bodies Products Concerned Implantable and Class III Devices Products listed in Annex 16 eligible Regulatory reference MDR (EU) 2017/745 Article 32 Documents mentioned EN...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
