Theme Summary of safety and performance (SSP) Target Audience Manufacturer Products concerned Class C and D IVD Documents mentioned Regulation (EU) 2017/746 This guidance presents the model of the summary of safety and performance (SSP). This one must be established...
Publications : Placing on the market
MDCG 2022-8 : Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
Theme Transitional provisions Target Audience Manufacturers, Authorised representatives, Importers, Distributors, Notified Bodies Products concerned IVD Documents mentioned IVDR (EU) 2017/746 IVDR – Article 110 Blue Guide MDCG 2019-5 MDCG 2021-13 rev.1 This...
MDCG 2022-7 : MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Theme UDI Target Audience Manufacturers, systems and procedure packs producers, kit producers Products concerned MD, IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 UDI FAQ MDCG 2018-1 MDCG 2018-6 MDCG 2021-19 MDCG 2021-27 COMMISSION IMPLEMENTING...
MDCG 2022-6 : Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
Theme Significant change under the transitional provisions Target Audience Manufacturer Products concerned IVD : legacy devices Documents mentioned Regulation (EU) 2017/746 Directive 98/79/EC MDCG 2020-3 Regulation (EC) 1272/2008 Regulation (EC) No 1907/2006 Q&A...
MDCG 2022-5 : Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
Theme Borderline between medical devices and medicinal products Target Audience Manufacturers Products concerned Borderline products Documents mentioned Directive 2001/83/EC Regulation (EU) 2017/746 Directive 93/42/EEC Regulation (EU) 528/2012 Directive 2004/27/EC...
Christophe Claudon
After more than 20 years in medical device industry (manufacturing, quality and regulatory), I have started my new nexialist challenge in February 2022 as Quality Consultant with one main focus “THE PATIENT”, thus product safety. I worked for medical device supplier...
Amina Mlaiki
Graduated from a multidisciplinary course in Sport Ergonomics and Motor Performance at the Faculty of Sport Sciences of Luminy. I am currently in Master 2 Bio-Engineering of Tissues and Implants. As part of my end-of-study internship, I am joining Nexialist for a...
Séverine Gossé
I joined nexialist in July 2016, after several years of experience in tourism and as a small business manager. Today, my experience and knowledge benefit nexialist’s team. I mainly assist administrative and financial work as well as management and organization. It is...
Saveria Dormenval
I joined nexialist on April 01, 2021 after 3 years of experience in the field of medical devices. I graduated as a biomedical engineer (ISIFC) in 2017 and then worked as a certification and validation engineer for an active medical device. I have developed skills on...
Nicolas Gramond
Graduated with a Master in Biomechanics, Ergonomics and Product Design and a Sports Coaching degree, I have always had health and safety in mind through product ergonomics and human movement. I joined nexialist in 2018 as a product compliance consultant specialized on...