MDD (Medical Device Directive) Compliance Review checklist wanted

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lennon121

Does anybody have a MDD compliance review checklist handy?
 
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lennon121

I'm completing a gap analysis for a new medical device to be included in our scope of certification, an essential requiement checklist would form part of the complaince check so in that case I would assume both!?!
 
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Gert Sorensen

Here is an ER checklist. My RA colleagues have never heard of an "MDD compliance review checklist", so I can't help you there.
 

Attachments

  • ESSENTIAL REQUIREMENTS.docx
    33 KB · Views: 688
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SteveK

I am afraid Gert has directed you to the OLD ER checklist. Go to the green ‘Post Attachments List’ above in the Elsmar banner and put ‘Essential Requirements’ as keywords. This will then pull up the 2007-47 template.

Steve
 

parr05

Starting to get Involved
Attached is the Check list I used recently. hope this help.
 

Attachments

  • EssRq chcklist incl.directive200747EEC.doc
    252.5 KB · Views: 334

Ronen E

Problem Solver
Moderator
Does anybody have a MDD compliance review checklist handy?

The MDD itself would be the checklist. Obviously the items to tick would largely depend on the nature of device (e.g. sterile / non-sterile), the classification and the route chosen (where choice is available).

I think reading the entire MDD from time to time is a good exercise for any RA professional dealing with the EC MD market. It helps fighting requirements creep (and Alzheimer too...:lmao:)
 
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