he CAMD network publishes FAQ documents covering the transitional provisions of the MDR and IVDR.
These documents were developed by the CAMD Transition Subgroup (TSG) which was tasked with agreeing and providing greater clarity on the transition-related provisions in the new Regulations.
The TSG has answered around 20 initial questions on the following topics:
- Placing on the market of MDR/IVDR compliant devices until 26 May 2020/2022
- Placing on the market of AIMDD/MDD/IVDD compliant devices after 26 May 2020/2022
- The so called “sell off” provision of Art. 120 para 4 MDR / Art. 110 para 4 IVDR
- EUDAMED and its relevance for the application of certain provisions of the MDR/IVDR.
These FAQs will evolve and expand as the TSG continues to address the key issues, and will act as an aid to the consistent interpretation of the transition articles.