MDR One-year Delay: Implications for medical device manufacturers

In February 2020, the first European countries began to be affected by the COVID-19 virus. During March, the rest of the pack followed and Europe went into lockdown. From the perspective of the implementation of the Medical Devices Regulation (EU) 2017/745 (MDR), this was very inconvenient. It became impossible to conduct on-site audits, staff were working remotely or with limitations, and many organizations had to shift their priorities to devices that were urgently needed for prevention, treatment, or monitoring of the COVID-19 pandemic. The European Commission did the right thing and proposed a delay of the date of application of the MDR by one year.

In this white paper, we will discuss what the one-year MDR delay means for medical device companies and how to continue planning your transition to the MDR.