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...
Theme UDI – Combination products Target Audience Manufacturers Products Concerned Combination products : - devices incorporating, as an integral part, a substance which, used separately, would be considered a drug - devices intended for the...
Theme Basic UDI-DI Target Audience UDI Issuing entities Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 IVDR (EU) 2017/746 Documents mentioned This guide provides some clarification on the format of the basic UDI-DI. The basic UDI-DI...
Theme Certificates Target audience Notified Bodies (NB) Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 58(1) IVDR (EU) 2017/746 Article 53(1) Documents mentioned This guide provides additional information on the content of...
Theme EUDAMED – UDI database Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 28(3) Annex VI part C section 5.10 Article 33(1a) Recitals 43-46 IVDR (EU) 2017/746 Article 25(3) Annex VI part C section 5.10...
Theme Obligations of persons referred to in Article 16 Target audience Persons referred to in Article 16 Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 16 IVDR (EU) 2017/746 Article 16 Documents mentioned This guide provides...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
