ISO 13485 & EU MDR / MDR Deadline
We are a Class I and Ir dental hand instrument Manufacturer, Repackage and relabeled. We have never been certified to EU MDD or EUMDR. When is our deadline to get a Notifying body to accept us and to complete our MDR certification?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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For class I, you do not need the Notified body. What you need is to implement ISO 13485:2016, and then certification body will audit your Quality Management System according to ISO 13485.
For medical device class Ir, you need to certify it under the MDR by May 2024. There is no postponement for these device classes.
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