Medical Device Reporting Procedures compliant with FDA and CE Marking Requirements

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curiousone

Could anyone advise me on MDR procedures? I am in the process of writing a controlled document of procedures to follow for medical device reporting. I would like to incorporate our current FDA procedure with a new procedure for CE.
Would anyone like to share an example or template for such procedures?
 

rob73

looking for answers
Re: Medical Device Reporting Procedures

A good place to start is to read the attached, this pretty much spells out the EU vigilance system, as we do not supply to the US of A I could not comment on a procedure that covers both:(
Good luck!
Rob
 

Attachments

  • 2_12_1-rev_6-12-2009_en.pdf
    296.2 KB · Views: 393
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SteveK

Re: Medical Device Reporting Procedures

Could anyone advise me on MDR procedures? I am in the process of writing a controlled document of procedures to follow for medical device reporting. I would like to incorporate our current FDA procedure with a new procedure for CE.
Would anyone like to share an example or template for such procedures?

I did post an SOP for EU recalls and advisory notices if that is any good. Go to this thread:

Medical Device Recall Procedure example wanted

Steve
 
C

curiousone

Re: Medical Device Reporting Procedures compliant with FDA and CE Marking Requirement

Steve, my thankfulness is immense!! You gave me exactly what I was looking for. I now will merge the information I received from you with my FDA reporting protocol. Once again, THANK YOU!!
I have found this site to be so helpful!:agree:
 
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SteveK

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curiousone

Re: Medical Device Reporting Procedures compliant with FDA and CE Marking Requirement

:confused:Steve K, in your procedures, you referred to MLD 11.07 regarding recalls. Could you explain what MLD stands for?
 
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SteveK

Re: Medical Device Reporting Procedures compliant with FDA and CE Marking Requirement

:confused:Steve K, in your procedures, you referred to MLD 11.07 regarding recalls. Could you explain what MLD stands for?

As part of the documentation system I inherited, forms etc were referred to “Master List Documents”. Thus these controlled documents have the prefix MLD followed by a number which designates a ‘family’ of forms (see attached).

Steve
 

Attachments

  • MLD 11.07 Copy.doc
    38 KB · Views: 244
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curiousone

Re: Medical Device Reporting Procedures compliant with FDA and CE Marking Requirement

Thanks Steve,
I came to that conclusion a little while ago; that it was an internal document. I thought at first that it was something that I was unaware of. Once again, thanks for all your help. I found your attachments to be quite useful as a guide for writing our procedures.
 
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