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.