Device certification date

MDCG 2022-21 uses this date to switch the PSUR schedule from the legacy rules to the MDR certificate. The guidance lists which certificate types count.

“Device certification date”: The “device certification date” used in this guidance should be understood as one of the following: - Date of issuance of the EU technical documentation assessment certificate according to Annex IX (including chapter II). - Date of issuance of the EU type-examination certificate according to Annex X. - Date of issuance of the EU product verification certificate for class IIa devices according to section 3 of Annex XI. - The date of signing of the Declaration of Conformity for Annex IX (Chapters I & III) devices. - Date of the issuance of the statement required in Annex XIII, section 1 for custom-made devices.

MDCG 2022-21, Section 1.2, Terminology