UK Registration Deadline: High-Risk Devices
11 May 2023Swiss-EU MRA Lapses for Medical Devices
11 May 2023
- All devices new to the market must be CE Marked to the MDR.
- All devices that are Class I self-certified under both MDD and MDR, must be CE Marked to the MDR as of today to continue being placed onto the market.
- MDD Class I self-certified devices which were up-classed under the MDR and Class I sterile, Class I measuring, IIa, IIb and III devices with valid MDD or AIMDD Notified Body issued CE Marking may continue marketing through the transition periods outlined in MDR Article 120(3). Certain conditions apply.
