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...
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...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
