MDD inclusion in Quality Policy - MDD Annex 5, 3.2 was referenced

quest

Registered Visitor
#1
In 1997, during a CE audit, we were cited for not indentifying the MDD as 'one of the requirements that the company intended to comply with.' MDD Annex 5, 3.2 was referenced. As a result we added to our policy that we "operate in accordance with the Quality System Regulation as required by the U.S. Food and Drug Administration and the Medical Device Directive (93/42/EEC) of the European Economic Community."
We are reviewing (and shortening) our Quality Policy and the question came up whether this specific reference to FDA and MDD was required. Our QMS conforms to ISO13485 as well as cGMP.
I would appreciate your opinion on this. Can we remove the specific references or was the 1997 auditor correct?
 

Al Rosen

Staff member
Super Moderator
#2
quest said:
In 1997, during a CE audit, we were cited for not indentifying the MDD as 'one of the requirements that the company intended to comply with.' MDD Annex 5, 3.2 was referenced. As a result we added to our policy that we "operate in accordance with the Quality System Regulation as required by the U.S. Food and Drug Administration and the Medical Device Directive (93/42/EEC) of the European Economic Community."
We are reviewing (and shortening) our Quality Policy and the question came up whether this specific reference to FDA and MDD was required. Our QMS conforms to ISO13485 as well as cGMP.
I would appreciate your opinion on this. Can we remove the specific references or was the 1997 auditor correct?
I don't think you need to in your quality policy, but in the scope of your manual.
 

Aaron Lupo

Inactive Registered Visitor
#3
Al Rosen said:
I don't think you need to in your quality policy, but in the scope of your manual.
I agree, there is no reason to call out what you are going to comply with in your QP, however, in your QM you should reference the applicable standards, ISO 13485, FDA (Parts), MDD, etc..
 

quest

Registered Visitor
#4
Thank you

I agree. We do reference ISO, FDA and MDD in our QM so will take it out of the QP. Thank you for your inputs.
 

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