Publications : Qualification

MDCG 2022-18 : MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate – December 2022

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...

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Yani Ammar

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...

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Laurence Corral

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...

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Marian Kunde

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,...

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Alexis Kresser

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...

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MDCG 2022-16 : Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – October 2022

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...

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MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD – Septembre 2022

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 –...

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