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MDR Date of Application

26 May 2021
  • 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. I.e., these devices are not eligible for “legacy” device status.
  • 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.

Details

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Legislation
EU MDR
Region
Europe