Exclusion of chapter 7.5 production for clinical investigation

[swiss quality]

We used to have a full ISO 13485 certification incl. production (7.5) for many years. The auditor of the certification body complained several years, that we don't produce and bring medical devices on the market (which is true). We do only develop up until a clinical investigation and then we sell the IP or spin off.
So we changed the scope and excluded 7.5 and he was happy.
No we got a new auditor (same Swiss certification body) and he now wants 7.5 back described completely, because we are planning a clinical investigation for a developed medical device (investigational device). The package for the investigational device currently has our company name prinetd as manufacturer.
We are now totally confused.
Do we need to describe 7.5 in our system for a clinical investigation only? We will never bring anything on the market ourselves.

 

[somashekar]

We used to have a full ISO 13485 certification incl. production (7.5) for many years. The auditor of the certification body complained several years, that we don't produce and bring medical devices on the market (which is true). We do only develop up until a clinical investigation and then we sell the IP or spin off.
So we changed the scope and excluded 7.5 and he was happy.
No we got a new auditor (same Swiss certification body) and he now wants 7.5 back described completely, because we are planning a clinical investigation for a developed medical device (investigational device). The package for the investigational device currently has our company name prinetd as manufacturer.
We are now totally confused.
Do we need to describe 7.5 in our system for a clinical investigation only? We will never bring anything on the market ourselves.

Hi .. I hope your justification for Clause 7.5 non-application is well detailed. Hope you can share it here.
If I were in your place, I would rather state that 7.5.1 as Non-applicable with proper justification, likewise for the other Clauses 7.5.x. I would definitely have 7.5.8 applicable and then have a simple procedure to describe how product is identified in the clinical evaluation phase, and follow that in product identification at Clinical evaluation. Note that 7.5.8 is applicable throughout product realization (Clause 7)
Now, The device you have made for clinical / performance evaluation is not considerd to be released for use to the customer, ie., the design output transfer to manufacturing has not happened. You therefore suitably label the device as "clinical evaluation device - Not released for use to customer". You can have your company name for identification without using the word "Manufacturer". Please see Clause 7.3.7 where in, it is clearly mentioned that Validation shall be completed prior to release for use of the product to the customer. Clinical evaluation is a part of Design and development validation.