Control of Records Retention Time as per ISO13485

[vijaygaddan]

Dear Elsmar Team,

We are in the process of moving to a different site and we are thinking of shredding documents we don't need.

ISO 13485 Requirement:
The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization.

Can I interpret the above as follows for the following records

1. Calibration Maintenance Records: 2 years
2. External Audit Reports: life of the medical device (LOMD)
3. Device History File: Life of the Medical Device (LOMD)
4. Device History Record: 2 Years
5. Training Records: LOMD
6. Management Reviews/internal Audits: LOMD
7. Receiving Inspection files: 2 years
8. NCMRs, CAPAs, Supplier Files, First articles: LOMD
9. Purchase orders/Sales orders: 2 years
10. Complaint investigations, MDRs, Field Notifications: LOMD
11. Warehouse Temp/Humidity Records: 2 years

Please advise.

 

[Tidge]

My instincts are to be a 'data hoarder', so keep this in mind. I should also note: I don't know what type of medical device is being manufactured.

I feel like some of these may be at odds, for example "training records" and "device history record".

Management Review/Internal Audits don't usually align with LOMD, those are more QMS elements.

Receiving/Inspection might be too short if the components don't immediately end up in a medical device.

 

[Nichole F]

Make sure you are also referencing the record retention requirements for the market you plan to sell into. EU, for example, requires product documents to be kept for 10 years or 15 for implantable devices. Some of the non-product documents (like management review and training records) don't maintain the same retention requirements. Most companies I've seen do 5 years for management review. Employment records, including training records, may depend on employment laws outside of medical device regulations so be sure you know what applies to your situation.

 

[vijaygaddan]

Make sure you are also referencing the record retention requirements for the market you plan to sell into. EU, for example, requires product documents to be kept for 10 years or 15 for implantable devices. Some of the non-product documents (like management review and training records) don't maintain the same retention requirements. Most companies I've seen do 5 years for management review. Employment records, including training records, may depend on employment laws outside of medical device regulations so be sure you know what applies to your situation.

Good Point. Our devices are not implantable.

 

[vijaygaddan]

My instincts are to be a 'data hoarder', so keep this in mind. I should also note: I don't know what type of medical device is being manufactured.

I feel like some of these may be at odds, for example "training records" and "device history record".

Management Review/Internal Audits don't usually align with LOMD, those are more QMS elements.

Receiving/Inspection might be too short if the components don't immediately end up in a medical device.

Goof feedback. thanks !

 

[Billy Milly]

Depends on the device shelf life. If shelf life is <2 years, you are pretty close.
Maybe you can consider scanning your archive.

 

[ChrisM]

"The organization shall retain the records for at least the lifetime of the medical device as defined by the organization...."
Hopefully your device has a lifetime of at least 2 years.... IMHO 2 years is too soon to be discarding any documentation.
My understanding was that lifetime was not the specific lifetime of a single device in question, but the device as a whole. So if the device was in production for 10 years but had to be discarded after 3 years for some obscure reason, you would need to retain all relevant records for at least 10 years. You also have to consider the possibility of someone bringing a case of legal action against you for a device that was made a number of years ago.... taking into account how long legal processes can take etc, it would be wise to consider retaining some records for at least 20 years. I note from your original post that you appear to have done this but I'd query some of the retention times - Purchase Orders, for example, I'd keep for at least 10 years rather than two.

 

[vijaygaddan]

"The organization shall retain the records for at least the lifetime of the medical device as defined by the organization...."
Hopefully your device has a lifetime of at least 2 years.... IMHO 2 years is too soon to be discarding any documentation.
My understanding was that lifetime was not the specific lifetime of a single device in question, but the device as a whole. So if the device was in production for 10 years but had to be discarded after 3 years for some obscure reason, you would need to retain all relevant records for at least 10 years. You also have to consider the possibility of someone bringing a case of legal action against you for a device that was made a number of years ago.... taking into account how long legal processes can take etc, it would be wise to consider retaining some records for at least 20 years. I note from your original post that you appear to have done this but I'd query some of the retention times - Purchase Orders, for example, I'd keep for at least 10 years rather than two.

thanks for your feedback !

 

[vijaygaddan]

The requirement we have for IVDD

• 5 years after the last device was manufactured (Medical Device Directive 93/42/EEC and in vitro Diagnostic Medical Devices Directive 98/79/EC)

for IVDR: The legal manufacturer shall keep technical documentation EU declaration of conformity, relevant certificates, amendments and supplements (Article 51 & 56) for at least 10 years.

 

[d_addams]

items 1, 4, and 7 would seem to be relevant for the life of the device, particularly if these contain information demonstrating components were conforming and that equipment used to make quality determinations were in proper working order.