New rules for Artificial Intelligence – Questions and AnswersNew rules for Artificial IntelligenceThe new rules for artificial intelligence are a set of guidelines developed by the European Commission to regulate the use of artificial intelligence (AI) in the European...
Proposed Regulation on Artificial IntelligenceArtificial Intelligence RegulationThe publication in April 2021 of the European Commission’s proposal for a European regulation on artificial intelligence is part of a global desire by all stakeholders to define the...
Theme Substantial modification of performance study Target Audience Sponsors, Competent authorities Products concerned IVD Regulatory reference IVDR (EU) 2017/746 Article 66(1) Article 70(1) Article 71 Documents mentioned MDCG 2022-19 As the EUDAMED database is...
Theme Application/notification for performance studies Target Audience Sponsors, Competent authorities Products concerned IVD Regulatory reference IVDR (EU) 2017/746 Article 66 Article 69 Article 70(1) Documents mentioned MDCG 2022-12 As the EUDAMED database is...
Theme Legacy devices Target Audience Manufacturers, Notified bodies Products concerned MD Regulatory reference MDR (EU) 2017/745 Documents mentioned MDCG 2020-3 MDCG 2021-25 This position paper concerns legacy medical devices, i.e. devices with an MDD or AIMDD...
Theme Hybrid audits Target Audience Notified bodies, Manufacturers Products concerned MD/IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2020-4 MDCG 2020-17 MDCG 2022-14 This MDCG document clarifies the definitions and...
From a training focused on the creation of medical devices and the challenges around its design in terms of biomechanics and biocompatibilities. I pursued the construction of my knowledge at the international level by carrying out an R&D project for class III...
My career path has allowed me to explore different visions of the medical device field: the vision of the industry, mainly as Regulatory Affairs Manager, and then that of the notified body as Technical Documentation Evaluator. These different experiences have forged...
Following a beginning of study in physics and engineering science where I did not see the end. I became a self-taught photographer, which led me to try to share as much as possible the art I was producing. So I learned about techniques to catch the eye of the crowd,...
Switzerland non-renewal of the Mutual Recognition Agreement with the EU: adjustments or real upheaval?Switzerland - non-renewal of the Mutual Recognition Agreement with the EU: adjustments or real upheaval?Since 2002, a Mutual Recognition Agreement (MRA) has linked...
