Theme Transitional provisions – Conformity Assessment - EURL Target Audience Manufacturers, Notified Bodies Products concerned Class D IVD Documents mentioned IVDR (EU) 2017/746 This guide in the form of questions and answers provides indications on how to...
Theme Custom-Made, Adaptable and Patient-Matched medical devices Target Audience Manufacturers Products concerned MD Documents mentioned MDR (EU) 2017/745 Article 2(3), 16(1) Annex XIII IMDRF/PMD WG/N49 FINAL:2018 This document aims to answer questions...
Theme Performance evaluation - COVID-19 Target Audience Manufacturers Products concerned IVD Documents mentioned Directive 98/79/EC Annexes I & III IMDRF/GRRP WG/N47 FINAL:2018 This new MDCG guide focuses on the state of the art of COVID-19 rapid antibody...
Theme EUDAMED Target Audience Economic Operators, Notified Bodies, Sponsors, Member-State, European Commission Products concerned MD - IVD Documents mentioned MDR (EU) 2017/745 – Article 123(3) (d) Directive 93/42/EEC Directive 90/385/EEC This 31-page guide...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
