Theme Expert panel consultation referred to in article 48(6) of Regulation (EU) 2017/746 Target Audience Notified bodies - Manufacturers Products concerned IVD Documents mentioned IVDR (EU) 2017/746 Directive 98/79/EC This MDCG guide sets out criteria to be...
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MDCG 2021-21 Rev. 1 : Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices – August 2021
Theme COVID-19 – Performance evaluation Target Audience All stakeholders Products concerned IVD Documents mentioned IVDR (EU) 2017/746 Directive 98/79/EC This document details the performance evaluation conditions for IVD’s intended for the detection or...
MDCG 2021-20 : Instructions for generating CIV-ID for MDR Clinical Investigations – July 2021
Theme Eudamed2 – Clinical investigations Target Audience Competent authorities, clinical investigations sponsors Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-1 Rev.1. This guide provides Competent Authorities (CA) with the necessary...
MDCG 2021-19 : Guidance note integration of the UDI within an organisation’s quality management system – July 2021
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...
MDCG 2021-17 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) – July 2021 MDCG 2021-18 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) – July 2021
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...
MDCG 2021-15 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) – July 2021 MDCG 2021-16 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) – July 2021
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...
MDCG 2021-14 : Explanatory note on IVDR codes – July 2021
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...
MDCG 2021-13 Rev. 1 : Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR – June 2021
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...
MDCG 2021- 12 – FAQ on the European Medical Device Nomenclature (EMDN) – May 2021 – V1.1
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...
MDCG 2021-11 : Guidance on implant card ‘Device types’ – May 2021 – V1.1
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...
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