Medical Device Technical Files (Class IIa & IIb) ? Design Development Documentation

S

SteveK

#1
Medical Device Technical Files (Class IIa & IIb) – Design Development Documentation

With the imminent implementation of the updated MDD (21.3.10), I am currently putting together new electronic versions (pdf files) of our Technical Files (14 in total – headache!). The reason being is that our NB has requested them in this format. Anyway, there will now be a requirement for these files to be reviewed to some form of schedule separately from the annual surveillance audit (for an extra cost - naturally!). One problem is that many of these files originate from 1998 i.e. when the MDD/CE Marking requirements came into play – the original dossier section often relates to standards that are now out of date. Naturally, with the ‘state of the art’ requirement of the MDD, I have updated to new standards, including generating new test data where I can. The new TF contents are based on NB-MED 2.5.1/Rec5 Revision 4, as recommended by the NB (i.e include Risk Management, Clinical Evaluation, Essential Requirements, Drawing, Labelling, DoC etc sections). Question – with product designs as old as the Ark (well nearly 30 years old in some cases) would a NB expect to see design development documentation for such products? Would a retrospective review of how the design came about suffice or is this irrelevant if we indicate conformance to a current Standard? We did introduce a Design Development procedure – but that was back in 1993 (note this currently indicates document retention for up to 15 years). Any thoughts?

Thanks

Steve
 
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Stijloor

Staff member
Super Moderator
#2
Re: Medical Device Technical Files (Class IIa & IIb) – Design Development Documentati

With the imminent implementation of the updated MDD (21.3.10), I am currently putting together new electronic versions (pdf files) of our Technical Files (14 in total – headache!). The reason being is that our NB has requested them in this format. Anyway, there will now be a requirement for these files to be reviewed to some form of schedule separately from the annual surveillance audit (for an extra cost - naturally!). One problem is that many of these files originate from 1998 i.e. when the MDD/CE Marking requirements came into play – the original dossier section often relates to standards that are now out of date. Naturally, with the ‘state of the art’ requirement of the MDD, I have updated to new standards, including generating new test data where I can. The new TF contents are based on NB-MED 2.5.1/Rec5 Revision 4, as recommended by the NB (i.e include Risk Management, Clinical Evaluation, Essential Requirements, Drawing, Labelling, DoC etc sections). Question – with product designs as old as the Ark (well nearly 30 years old in some cases) would a NB expect to see design development documentation for such products? Would a retrospective review of how the design came about suffice or is this irrelevant if we indicate conformance to a current Standard? We did introduce a Design Development procedure – but that was back in 1993 (note this currently indicates document retention for up to 15 years). Any thoughts?

Thanks

Steve
Any help, thoughts, insights for Steve?

Thanks.

Stijloor.
 
R

Rob Udo

#3
Re: Medical Device Technical Files (Class IIa & IIb) – Design Development Documentati

Steve,

I don't guess the NoBo will see you to redo your design.

As far as I know they want to see a GAP analysis for all revised harmonized and applied standards. In other words: did you assess the impact of a changing standard on your product? Any gaps, i.e. actions to comply with the new requirements, should be demonstrable to the NoBo.

This can result in a redesign of a part of your product. That needs to be documented. You can not fully rewrite history.
 
S

SteveK

#4
Re: Medical Device Technical Files (Class IIa & IIb) – Design Development Documentati

Rob,

Thanks for the feedback. Conducting a GAP analysis is basically what I have done - old standard with current. The standards do not indicate that any design changes are required for our range of devices - anyway if they did, that could lead to submitting technical files sooner rather than later to the NB (e.g. if regarded as 'substantial' by the guidelines). As indicated, getting some updated/retrospective testing done to a new standard can be an issue - limited places that do the testing (if any)/high cost, not to mention rather dubious requirements (e.g. why test a low pressure medical hose assembly at 350Lpm when a normal operating rate is typically no more that 15Lpm e.g. for oxygen therapy - BS EN ISO 5359:2008?) - my problem though!

Steve
 

bio_subbu

Super Moderator
#5
Re: Medical Device Technical Files (Class IIa & IIb) – Design Development Documentati

With the imminent implementation of the updated MDD (21.3.10), I am currently putting together new electronic versions (pdf files) of our Technical Files (14 in total – headache!). The reason being is that our NB has requested them in this format. Anyway, there will now be a requirement for these files to be reviewed to some form of schedule separately from the annual surveillance audit (for an extra cost - naturally!). One problem is that many of these files originate from 1998 i.e. when the MDD/CE Marking requirements came into play – the original dossier section often relates to standards that are now out of date. Naturally, with the ‘state of the art’ requirement of the MDD, I have updated to new standards, including generating new test data where I can. The new TF contents are based on NB-MED 2.5.1/Rec5 Revision 4, as recommended by the NB (i.e include Risk Management, Clinical Evaluation, Essential Requirements, Drawing, Labelling, DoC etc sections). Question – with product designs as old as the Ark (well nearly 30 years old in some cases) would a NB expect to see design development documentation for such products? Would a retrospective review of how the design came about suffice or is this irrelevant if we indicate conformance to a current Standard? We did introduce a Design Development procedure – but that was back in 1993 (note this currently indicates document retention for up to 15 years). Any thoughts?

Thanks

Steve
Hi Steve

According to Article 11(10) of Directive 93/42/EEC “the notified body may require any information or data which is necessary for establishing or maintaining the attestation of conformity of the medical device in question”.

Since Directive 2007/47/EC, which will be applicable as of 21 March 2010, introduced new requirements regarding the design examination of devices of class IIa and IIb on a representative basis (e.g. section 7 of Annex II and sections 8 of Annex IV, section 6 of Annexes V and VI to Dir. 93/42/EEC).

The request of your notified body regarding the design development documentation may also be part of the assessment of your quality system which the notified body needs to carry out periodically and which include, among others, the assessment of the documentation of the design on a representative basis (e.g. see sections 3.3 and 5 of Annex II).

I recommend you to contact your notified body and get the suggestions for the same.

Regards
S. Subramaniam
 
S

SteveK

#6
Re: Medical Device Technical Files (Class IIa & IIb) – Design Development Documentati

Hi,

Thanks for the input. I have already been in contact with the NB relating to a ‘substantial’ design variation in a medical device family, this triggered the original question relating to other established devices.

Steve
 
R

Renym

#7
Re: Medical Device Technical Files (Class IIa & IIb) ? Design Development Documentati

Can I possibly see the gap analysis that you did? I am in the process of doing the same thing for old test data. We need a gap analysis for the revised testing standards.

Thanks,
Nick
 
S

SteveK

#8
Re: Medical Device Technical Files (Class IIa & IIb) ? Design Development Documentati

Can I possibly see the gap analysis that you did? I am in the process of doing the same thing for old test data. We need a gap analysis for the revised testing standards.

Thanks,
Nick
The attached is an example of a review (or gap analysis) of an old versus current standard that I have in a particular Technical File. This was recently reviewed (and accepted) by our NB. I included some new test data sheets to the new standard, but these were essentially design reviews relating to individual clauses and the odd retest e.g. for leakage.

Steve
 

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