Implementation of the IVDR: Regulation (EU) 2017/746 for in vitro diagnostic medical devices
May 19, 2022
On 26 May 2022, Regulation (EU) 2017/746 will come into force for in vitro diagnostic medical devices (IVDMDs). Full details of this new regulation (IVDR) are available at: https://eur-lex.europa.eu/eli/reg/2017/746/oj
Help is on hand to guide companies through the transition
- The French National Agency for the Safety of Medicines and Health Products (ANSM) recently hosted a webinar presenting the new classification rules, the timetable for the implementation of this new European regulation, and plans for the transition. Replays of the webinar are available here: https://www.youtube.com/watch?v=1yjnlBNNQHo
- Elsewhere, the European Society of Human Genetics hosted a dedicated, day-long, IVDR webinar, providing generation information about the new regulation, its impact on diagnostic laboratories, and practical approaches to obtain compliance. Replays of the sections of the webinar are available here: https://www.eshg.org/index.php?id=ivdrday
The expertise of Santé Active Edition – Synergy Pharm
Specialists in medical writing, our experienced team has the skills needed to accompany you in the drafting of your regulatory documentation: clinical evaluation reports (CERs) including state of the art and literature reviews, as well as all the documentation related to your clinical investigations (CIs), such as investigator brochures (IBs), clinical study reports (CSRs), and more.
We can also support you in writing the scientific article relating to your clinical investigation.
Recent examples of articles about IVDMDs written by our team include:
- Cancel-Tassin et al. World J Urol. 2021
- Ehret et al. J Clin Virol. 2022
Do not hesitate to contact us to discuss your projects!