Archived Specifications and Drawings for Medical Device Technical Files

LostLouie

LostLouie

Starting to get Involved
#1
#1
Dear fellow Covers, I've been requested to create a Specification list for our Technical Files. I wondered if the regulations instruct that we need to document past revisions of drawings and specifications in these files (as I can't find where they do)?
Thanks in advance.
 
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Y

yodon

Staff member
Super Moderator
#2
#2
If you're talking about the Technical File that's reviewed by a Notified Body, that's a snapshot of a particular instance (and updated as things change). Your Document Control and Record Control procedures, though, have to address retention (of obsolete materials). There ARE regulations for those; e.g., see MDR Article 10, item 8.
 
M

monoj mon

Quite Involved in Discussions
#3
#3
LostLouie said:
I wondered if the regulations instruct that we need to document past revisions of drawings and specifications in these files
Click to expand...
If your past revisions are linked to 'previous generation(s)' then,
MDR 2017/745, Annex II, Section 1.2 (a) 1631064720663.png
MDR 2017/745, Article 32, Section 2 (c)
1631064852680.png
No particular instruction on to include 'drawings and specification', but I guess to describe the differences/similarities you would need one!
 
LostLouie

LostLouie

Starting to get Involved
#4
#4
yodon said:
If you're talking about the Technical File that's reviewed by a Notified Body, that's a snapshot of a particular instance (and updated as things change). Your Document Control and Record Control procedures, though, have to address retention (of obsolete materials). There ARE regulations for those; e.g., see MDR Article 10, item 8.
Click to expand...
Thank you for this reference.
 
LostLouie

LostLouie

Starting to get Involved
#5
#5
monoj mon said:
If your past revisions are linked to 'previous generation(s)' then,
MDR 2017/745, Annex II, Section 1.2 (a) View attachment 28166
MDR 2017/745, Article 32, Section 2 (c)
View attachment 28167
No particular instruction on to include 'drawings and specification', but I guess to describe the differences/similarities you would need one!
Click to expand...
Thanks so much for this confirmation. Can I assume that it is purely an MDR requirement? (ISO 13485:2016 only states "..relevant versions of applicable documents are available ..." )
 
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