Which classification rules apply to determine whether the extended transitional period ends on 31
December 2027 or on 31 December 2028?
For the purpose of Article 120(3a) MDR, which provides for the new transitional periods depending on the device's
risk class, the classification rules laid down in Annex VIII to the MDR apply. In certain cases, where the classification
rules of the MDR result in a different risk class, the device's risk class indicated on the certificate may differ from the
risk class that determines the end date of the transitional period.
However, where during the transitional period the risk class of a device is needed to determine applicable MDR
requirements (e.g. in relation to PSUR), the class of the device is the one established in accordance with the MDD
classification rules (see MDCG 2021-25)
Which classification rules apply to determine whether the extended transitional period ends on 31
December 2027 or on 31 December 2028?
For the purpose of Article 120(3a) MDR, which provides for the new transitional periods depending on the device's
risk class, the classification rules laid down in Annex VIII to the MDR apply. In certain cases, where the classification
rules of the MDR result in a different risk class, the device's risk class indicated on the certificate may differ from the
risk class that determines the end date of the transitional period.
However, where during the transitional period the risk class of a device is needed to determine applicable MDR
requirements (e.g. in relation to PSUR), the class of the device is the one established in accordance with the MDD
classification rules (see MDCG 2021-25)