MDR Regulatory Strategy: implementation guide

330,00 excl. VAT

The Medical Device Regulation (EU) 2017/745 (MDR) will become applicable on 26 May 2021.

Manufacturer may select to place on the Union market MDR compliant devices or MDD compliant devices based on the derogation to MDR Art. 5 provided in MDR Art. 120.3.  Regardless of the options chosen, manufacturers should establish, document, implement and maintain up to date a MDR Regulatory Strategy to place devices on the Union market from 26 May 2021, as per Art. 10.9 of the MDR.

This Guidance on the Drawing Up of a MDR 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: October 2020