Notification of the latest status of Minisart® medical devices

Dear customers,

Europe is currently in the midst of transitioning to Medical Device Regulation (MDR) 2017/746. Many medical device manufacturers have been faced with declined Notified Body capacities, resulting in longer waiting times for notification of new changes - which is also the case with Sartorius.

The latest changes (ECR17832, ECR24806, ECR25981) communicated in 2022 are still awaiting acknowledgement from Notified Body. These changes can only be implemented after receiving official acknowledgment. Since such extreme waiting times could not have been predicted in advance, we would like to remind you again about the most important and previously communicated changes and updates regarding Minisart® Medical Devices.

Change description:

1. ECR17832: Change of Bubble Point Value for CE-Labeled Minisart® HY -The Bubble Point (BP) specification for CE-marked Minisart® HY filters with 0.2 μm pore size has been reduced to 1.1 bar (16 psi).
2. ECR24806: Change of Instruction for Use for the CE-labeled Minisart® - To ensure the integrity of the filter, the maximum operating pressure for Minisart® HY/SRP in the direction OUT-IN should not exceed 1 bar. Despite the restriction, it is still possible to draw up solutions through the filter since this only creates a vacuum of less than or equal to 1 bar. In addition, the use of the EO sterilized Minisart® syringe filters must be restricted. They can no longer be used for premature neonates, stem cell and embryo related applications, to exclude any risk of EO residuals
3. ECR25981: Change of Labeling for the CE-Labeled Minisart® - To comply with the new ISO standard 15223-1 (Medical devices — Symbols to be used with information to be supplied by the manufacturer), Sartorius has revised the packaging labels and Tyvek foil label of the CE-labeled Minisart® product portfolio. The change affects only the products labeling. The production facility and production processes remain completely unchanged.

Read the latest status of the mentioned changes in the official Sartorius notification letter.

This change will apply from May 2024 onwards at the latest.