Publications : Biocompatibility

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...

read more

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...

read more

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...

read more

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,...

read more

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...

read more

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...

read more

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 –...

read more

Archives

Contact us

Le Forum Bat B
515 Avenue de La Tramontane
13600 La Ciotat
FRANCE

+33 (0)4 42 01 60 29
Write us