Commission Issues Corrections on MDR and IVDR

The Commission of the European Union (EU) has issued two “Corrigendums” in connection with its regulations applicable to medical devices and in vitro diagnostic devices.

Published in the Official Journal of the European Union in early May, the corrigendums generally correct errors in the original texts of the EU’s Medical Device Regulation (2017/745, also referred to as the MDR) and the In Vitro Diagnostic Medical Device Regulation (2017/746, also referred to as the IVDR). Typical errors corrected in the corrigendums include misspellings or incorrect references to other articles in the Regulations. But the corrigendums also include minor changes in the wording of certain phases in an effort to clarify the original intent.

The MDR and the IVDR were published in the Official Journal in May 2017. Medical device manufacturers have until May 2020 to ensure that existing medical devices are compliant with the provisions of the MDR, while manufacturers of in vitro devices have until May 2022 to demonstrate compliance with the IVDR.

Read the Corrigendum for the MDR.

Read the Corrigendum for the IVDR.

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