ISO 13485 Medical Device File requirements for IVD

C

costa58

Hello all, I am in charge of transitioning our QMS from ISO 9001 to ISO 13485. To give some background, we manufacture immunochemical reagents and also the IVDs that they are used in.

ISO 13485 clause 4.2.3 states that we need to maintain files to demonstrate conformity to the ISO and regulatory requirements (for example CE marking). Would this also apply to our immunochemical reagents, that are not defined as medical devices?

I assume that IVDs are technically a medical device, as they are a subset?
 

Ajit Basrur

Leader
Admin
Hello all, I am in charge of transitioning our QMS from ISO 9001 to ISO 13485. To give some background, we manufacture immunochemical reagents and also the IVDs that they are used in.

ISO 13485 clause 4.2.3 states that we need to maintain files to demonstrate conformity to the ISO and regulatory requirements (for example CE marking). Would this also apply to our immunochemical reagents, that are not defined as medical devices?

I assume that IVDs are technically a medical device, as they are a subset?

Welcome to the Cove :bigwave:

Yes, IVDs are considered medical devices.

Refer Overview of IVD Regulation for more information.
 
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