Do you manufacture devices incorporating artificial intelligence systems and wonder how the newly published AI Act will impact you? Read the rest of this article 😉 The key message to remember: The MD and IVD Regulations continue to drive DM/IVDs incorporating AI! The...
Theme Conformity assessment bodies assessment with a view to designation as a notified body Target Audience Conformity assessment bodies, notified bodies, designating authorities, joint assessment teams Products concerned MD, IVD Documents mentioned IMDR (EU)...
Theme Qualification of IVD Target Audience Manufacturers, NB Products concerned IVD Documents mentioned IVDR (EU) 2017/746 – article 2(2) et 2(4) The purpose of this guidance document is to clarify which products fall within the scope of Regulation (EU) 2017/746 on...
Theme Clinical evaluation Target Audience Manufacturers, NB Products concerned Orphan medical devices Documents mentioned MDR (EU) 2017/745 – article 60 Article 35 of the Charter of Fundamental Rights states These are guidelines for manufacturers and notified bodies...
Theme Re-assessment of notified bodies Target Audience Designating authority, NB Products concerned IVD Documents mentioned IVDR (EU) 2017/746 article 40(10) MDCG 2022-13 This document is a template form to be used by the designating authority in the context of the...
Theme Assessment of notified bodies Target Audience Designating authority, NB Products concerned IVD Documents mentioned IVDR (EU) 2017/746 – article 35 MDCG 2022-13 This guidance document is a form template to be used by the designating authority in the context of...
Theme Assessment of notified bodies Target Audience Designating authority, NB Products concerned MD Documents mentioned MDR (EU) 2017/745 – article 39 MDCG 2022-13 This guidance document is a form template to be used by the designating authority as part of the...
Theme Re-assessment of notified bodies Target Audience Designating authority, NB Products concerned MD Documents mentioned MDR (EU) 2017/745 article 46 MDCG 2022-13 This document provides a template form for use by designating Authorities (NAs) in the reassessment...
Theme Investigator’s brochure Target Audience Sponsor of clinical investigations Products concerned MD Documents mentioned MDR (EU) 2017/745 : – article 70 – Annex XV Chapter II Section 2 ISO14155:2020 This guidance document is intended to assist sponsors of...
Theme Safety reporting in performance studies Target Audience Sponsor of performance studies Products concerned IVD Documents mentioned IVDR (EU) 2017/746 : article 76 In a context where the Eudamed electronic system for performance studies is not available, this...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
