The new in vitro Diagnostic Regulation (EU) 2017/746 (IVDR) which replaces the IVD Directive (98/79/EC), entered into force on May 25th 2017, and will enter into legal application by 26 May 2022 after a 5-yeartransition period. Team-NB published a consideration...
Given the exceptional circumstances of the COVID-19 epidemic, the European Commission published a Notice on 11/01/2021 that temporarily allows notified bodies to perform remote conformity assessments of manufacturers QMS under the MDR/IVDR. Certain conditions...
Theme COVID-19 - Audit Target Audience Notified Bodies, Manufacturers, Subcontractors Products concerned MD, IVD Documents mentioned MDCG 2020-4 : Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine...
Theme UDI - EUDAMED Target Audience Manufacturers Products concerned Spectacle lenses and ready readers Documents mentioned MDR (EU) 2017/745 Article 10(7) Chapter III : Article 27, Article 27(3), Article 29, Article 31 Annex VI In this document, the Medical...
This table lists all the documents published by the Medical Devices Coordination Group (MDCG), and helps to know at a glance the theme, the target audience and the type of MD concerned for each document. Would you like to know more? Find the complete summary of each...
Theme Classification Target audience Manufacturers, Notified Bodies (NB) Products concerned IVD Regulatory references IVDR (EU) 2017/746 Annex VIII This MDCG document is a real mine of information for interpreting the classification rules of the IVD...
Theme EUDAMED Target audience Manufacturers, Importers, Authorised representatives, Persons as referred to in Article 22 (systems and procedure packs) Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 30(1) Article 31(2)...
Theme Surveillance audits MDR / MDSAP Target audience Notified Bodies (NB) Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Recital 32 Article 10(9) IVDR (EU) 2017/746 Recital 31 Article 10(8) Documents mentioned MDSAP Audit...
Theme Clinical evaluation Target audience Notified Bodies Products concerned MD Regulatory references MDR (EU) 2017/745 Article 61 Annex VII section 4.5.5 This document presents a template of a clinical evaluation assessment report (CEAR). This is the report...
Theme Specific additional procedures Target audience Notified Bodies, Manufacturers Products concerned · Devices containing a substance which may be considered a medicinal product and which has action ancillary to that of the device · Devices...