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...
Theme Implant Card Target Audience Manufacturers Products Concerned Implantable MD Regulatory reference MDR (EU) 2017/745 Article 18 Documents mentioned ISO database (Online Browsing Platform) ISO 15223-2 ISO/IEC 7810 ID-1 This document clarifies the contents...
Theme Person responsible for regulatory compliance - PRRC Target Audience Manufacturers and Authorised representative Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 and IVDR (EU) 2017/746 Article 15 Documents mentioned Commission Recommendation...
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...
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 case...
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...
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 body...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
