One of the biggest changes brought about by the new regulations on medical devices and in vitro diagnostics, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) respectively, is the creation of a European medical device database (EUDAMED). EUDAMED will...
The normative environment for the biological evaluation of medical devices has changed significantly in recent years. The 2018 version of ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process has led to...
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...
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 used by...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
