IVDR Regulatory Strategy: Implementation guide

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The In vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) will become applicable on 26 May 2022.

Manufacturer may select to place on the Union market IVDR compliant devices or IVDD compliant devices based on the derogation of IVDR Art. 5 provided in IVDR Art. 110.3.

Regardless of the options chosen, manufacturers should establish, document, implement and maintain up to date an IVDR Regulatory Strategy to place devices on the Union market from 26 May 2022 as per Art. 10.8 of the IVDR.

This Guidance on the Drawing Up of an IVDR Regulatory Strategy and associated procedures aims at identifying the topics which need to be addressed at a high level for the Regulatory Strategy and further specified in individual instructions or procedures.


Date of publication: September 2021