Hello Yamini,
For the EU IVDR, there is the regulation itself 2017/746, some published MDCG guidance documents on classification, UDI, etc., and there are presentations/white papers out there on the process. I might suggest if you are interested in switching from medical device to IVD medical device, you take a training course or even obtain a mentor who can assist in guiding through those activities. While many of the regulatory activities are the same between medical device and IVD medical device, there are also some differences.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Dec-2021 20:28
From: Yamini Nidumolu
Subject: IVD Job Duties
Hello,
I am switching between EU MDR job role to IVDR. I came across a job opportunity which interests me and states responsibilities as
1. Generate regulatory submission for the new product which is IVDR in the EU
2. Renew Existing product in EU
3. Change management etc
Can anyone guide me what is necessary procedures an International RA can look up for within US and EU?
Thank you,
Yamini
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Yamini Nidumolu
Regulatory Affairs Label Engineer
Lake Stevens WA
United States
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