S
SteveK
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the MDD/CE Marking requirements came into play – the original dossier section often relates to standards that are now out of date.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
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the MDD/CE Marking requirements came into play – the original dossier section often relates to standards that are now out of date.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