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Does Medicine Product Class 1 need Certificate from Notified bodies according to ISO 13485?

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Guest user Created:   Feb 18, 2021 Last commented:   Feb 18, 2021

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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Kristina Zvonar Brkić Feb 18, 2021

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:

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Feb 18, 2021

Feb 18, 2021