March 10 2022
Following the success of the 1TALK event on November 30th, 1MED team is organizing in-depth webinars on the main regulatory and clinical issues necessary for the transition from MDD to MDR.
The aim is to provide companies with clear information to create the necessary awareness to facilitate the adoption of MDR and offer information on the impact of the New Regulation on the products currently on the market.
Our first webinar of 2022 opened a discussion on the “TOP 5 most urgent tasks for MDR compliance before 2024”.
The conditions for legacy medical devices are changing rapidly following the implementation of the MDR on May 26, 2021. The new MDR requirements aim to improve product safety by putting patient health at the center, requiring manufacturers and all stakeholders to make a greater effort to raise the level of quality of the products, technical documentation and clinical data for the recertification that will have to take place within May 26, 2024. All of the above leads to companies to align with the new requirements with further urgency in an already critical context for the medtech industry considering that:
• According to the latest surveys carried out by Team-NB and the European Commission, most valid MDD Certificates expire in the first five months of 2024;
• Only 25 Notified Bodies are currently designated for MDR versus 51 that were designated for MDD;
• Only a very small number of MDR certificates have been issued so far (502 MDR certificates as of September 2021).
These circumstances are inevitably leading to an extremely critical situation. The purpose of the webinar is to investigate the 5 most urgent aspects to be implemented before May 26, 2024 to support manufacturers in this transition process. Join the free webinar for more details!