EU GDPR General Data Protection Regulation - What we need to update for our QMS

FoGia

Involved In Discussions
#11
Presumably these fall into the "processing is necessary for compliance with a legal obligation to which the controller is subject;" (Article 6(1)(c)) category, no?

I agree, I just wanted to point out that it is also a source of personal/sensitive data that ought to be tracked. Even if you have a legitimate interest to process/store the data that allows you to not seek consent or to deny the right to be forgotten for instance you still need to put in place measure to store the data securely, define a date at which the information will be deleted, measures to mitigate the risk,... etc.
 
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Kuldeep Singh

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#12
Hello ,

I am looking for scope of DIRECTIVE 95/46/EC OF THE EUROPEAN PARLIAMENT (Now REGULATION (EU) 2016/679 GDPR) . Can anyone guide me, how to show compliance with this. Basically i am trying to show complies with eIFU directive EU 207/2012 , Article 7 where we have to show compliance with this directive for our X-Ray Diagnostic Medical Device (CT Scan machine).

Further, We are plan to provide the IFU in electronic form as well as paper form. So please guide me applicable Articles of eIFU Directive EU 207/2012. As i read the directive , I come to know that only Article 9 applicable to us. Rest of articles applicable to manufactures which provide the IFU in electronic form only.

Thanks in advance.
 

Mark Meer

Trusted Information Resource
#13
...I am looking for scope of DIRECTIVE 95/46/EC OF THE EUROPEAN PARLIAMENT (Now REGULATION (EU) 2016/679 GDPR) . Can anyone guide me, how to show compliance with this. Basically i am trying to show complies with eIFU directive EU 207/2012 , Article 7 where we have to show compliance with this directive for our X-Ray Diagnostic Medical Device (CT Scan machine. ...
Hello Kuldeep. I'm not certain how you're relating eIFU & GDPR Directives. The GDPR is related to personal information (for example, that of your customers), whereas presumably your eIFU is strictly the manufacturer's (i.e. your) property, in which case I don't think you have to worry about GDPR requirements.
 

Kuldeep Singh

Involved In Discussions
#14
Hello Kuldeep. I'm not certain how you're relating eIFU & GDPR Directives. The GDPR is related to personal information (for example, that of your customers), whereas presumably your eIFU is strictly the manufacturer's (i.e. your) property, in which case I don't think you have to worry about GDPR requirements.
Thanks you Mark Meer,

Can you please also help me by suggesting for my query as i discuss in second paragraph of #12.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#15
You may be able to shed some requirements if you are a data processor and not a controller. As a processor, we added a dozen business SOPs to our QMS.
 
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