From MDD and AIMDD to MDR

1. WHY YOU NEED TO TAKE ACTION NOW

While the date of application in May 2024 may seem far away at present, the time until then will be shortened by the following factors: 

1. The efforts involved in transitioning to the new requirements are frequently underestimated. 
2. Any MDD and AIMDD certificates still valid will expire on 26 May 2024 at the latest. While there were 58 Notified Bodies providing certification in accordance with the MDD and AIMDD in 2020 only 27 Notified Bodies are offering certification in accordance with the MDR at present. The German Medical Technology Association (BVMed) is warning of bottlenecks at Notified Bodies for this reason. 
3. The transition of the already existing portfolio of devices (legacy devices) to the MDR requires significant additional input of resources on the part of manufacturers. To prevent internal resource constraints, experts recommend making an immediate start on the certification process in accordance with the MDR.

To work with you on shaping the transition phase from the MDD and AIMDD to the MDR, we have assembled more in-depth information for you on this page.