T-30 days before the 26 May 2024 deadline: manufacturers of medical devices in classes higher than I must have submitted an application to a Notified Body and brought their QMS into compliance with MDR 2017/745.
🚨 𝐓-𝟑𝟎 days before the important 𝟐𝟔 𝐌𝐚𝐲 𝟐𝟎𝟐𝟒 deadline for Medical Devices 📅
For manufacturers of Medical Devices in classes higher than I, the MDR 2017/745 transition period is underway. Here are the key steps not to miss:
• Submitting an application to a Notified Body (NB): Make sure you have approached a Notified Body and submitted a request for conformity assessment of your MD before 26 May 2024.
• Compliance of your Quality Management System (QMS): Ensure your QMS is compliant with MDR 2017/745 by this same deadline.
Anticipating these steps is essential to maintain your products on the market!
The next key step? Contracting with a Notified Body next September.
T-30 days before one of the deadlines in the MDR 2017/745 transition period: 26 May 2024.
Initiate an assessment request with a Notified Body.
Ensure compliance of your QMS.
