Theme UDI Target Audience Manufacturers Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2018-1 v4 MDCG 2018-3 Rev.1 MDCG 2018-4 MDCG 2018-5 MDCG 2018-6 MDCG 2018-7 IMDRF/UDI WG/N48 FINAL: 2019 This MDCG guide...
Theme Designation as notified bodies Target Audience Conformity assessment bodies Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 Commission implementing regulation (EU) 2017/2185 These MDCG guides (17 and 18) are the...
Theme Designation as notified body Target Audience Conformity assessment bodies Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 These MDCG guides (15 & 16) correspond to the forms to be completed by conformity assessment...
Theme IVDR Codes Target Audience Notified bodies, Manufacturers Products concerned IVD Documents mentioned IVDR (EU) 2017/746 Commission Implementing Regulation (EU) 2017/2185 MDCG 2019-11 This document provides details of the designation codes for Notified...
Theme EUDAMED Target Audience Actors other than manufacturers, authorised representatives, and importers Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2019-5 MDCG 2021-3 This document provides information on the...
Theme European Medical Device Nomenclature (EMDN) Target Audience All actors Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 Article 26 IVDR (EU) 2017/746 Article 23 This MDCG provides details on the nature, structure and implementation of...
Theme Implant card Target Audience Manufacturers Products concerned Implantable Medical Device Documents mentioned MDR (EU) 2017/746 Article 18 MDCG 2019-8 This document provides a non-exhaustive list of implantable medical "device types" to assist...
Theme UDI Target Audience Manufacturer Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 Annex VI IVDR (EU) 2017/746 IMDRF/UDI WG/N48 FINAL: 2019 MDCG 2019-11 This document is intended to provide interpretations on how certain principles and...
Theme UDI Target Audience Manufacturer Products concerned MD (contact lenses, spectacles frames, spectacles lenses and ready readers) Documents mentioned MDR (EU) 2017/745 Chapter III Annex VI MDCG 2020-18 This position paper is intended to provide further...
Theme Clinical investigations Target Audience Sponsors Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-1 Rev.1 This guide lists all the useful documentation for clinical investigation requests in accordance with the MDR (EU) 2017/745 and...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
