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.
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.
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
read moreAre you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if
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