Download the AssurX "EU MDR and IVDR Timeline" Infographic
What should companies be doing now to prepare?
The first steps for medical device compliance are understanding which devices need to be certified (or re-certified) by May 26, 2021. From there, companies need to get ready for certification audits by notified bodies (NBs), which includes adding new staff for non-EU companies, updating the QMS, and preparing documentation.
Let’s look at some of the details around these action items, and what’s next on the horizon in terms of MDR timelines.
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