Does Medicine Product Class 1 need Certificate from Notified bodies according to ISO 13485?
I attended the Webinar “Overview of steps needed to comply with EU MDR”
Who needs to get certified: included Manufacturer of Class 1 medical devices. What do you mean by certifying? Does it mean to get certified by ISO 13485:2016?
To be honest I have studied the complete EU MDR. By attending your Seminars and Q/A sessions. I understand the Medicine Product Class 1 does not need the Certificate from Notified bodies according to ISO 13485.
We just need to prepare our QMS according to ISO 13485 and EU MDR.
If I am understanding it wrong please guide me accordingly.
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Regarding the certification of medical devices, we must separate two things: one is the certification of the quality system according to ISO 13485: 2016, and the other is the certification of products and the issuance of the CE mark according to the MDR.
Manufacturers of Class I medical devices do not need a notifying body for product certification. So, they themselves issue the Declaration of conformity and put the "CE" mark on their medical products, but the CE mark without a number (for example, they put the CE mark on the product, and not CE2460).
Manufacturers of Class I medical devices need to prepare a quality system in accordance with ISO 13485 and be certified according to that standard.
For more information, please see the following:
- EU MDR – Easy-to-understand basics https://advisera.com/13485academy/what-is-eu-mdr/
- How can ISO 13485 help with MDR compliance? https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/
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Feb 18, 2021