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...
After getting my STI2D graduation, I chose the path of a BTS SIO (Computer Service to Organizations) SISR option (Infrastructure system and network solution) in apprenticeship in order to develop my skills and acquire a first professional experience over a long...
Theme Authorised representatives’ obligations Target Audience Authorised representatives, Manufacturers and other economic operators Products concerned MD/IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2019-7MDCG 2019-13MDCG...
Theme Transitional provisions Target Audience Notified Bodies (NB) Products concerned IVD Regulatory reference IVDR (EU) 2017/746Article 110 Documents mentioned MDCG 2022-4MDCG 2022-6MDCG 2022-8MDCG 2019-10 rev.1MDCG 2022-12CAMD MDR/IVDR Transition subgroup : FAQ –...
