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

9 Jan 2023 | All the News, MDCG, MDCG

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...
Yani Ammar

Yani Ammar

24 Nov 2022 | The team

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...
Laurence Corral

Laurence Corral

24 Nov 2022 | The team

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...
Marian Kunde

Marian Kunde

24 Nov 2022 | The team

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,...