ISO 13485 Quality Record Retention Period

[NathanNazareth]

I’m currently updating our Control of Records SOP in response to the following feedback from a GAP/pre-certification audit:

"The control of records procedure did not define the time that records must be retained"

However I am struggling to find an official retention period for quality records. Can anyone confirm the official retention time/period for quality records under 13485?

I have checked the Medical Device Directory (93/42/EEC) and states it’s “5 years after the last product has been manufactured”.

So does this mean 5 years plus the lifetime of the product/device (e.g. lifetime of product is 10 years so 15 years total retention time), or is it just 5 years after the last product has been manufactured?

And I assume this stated retention period applies to IVD Devices (non-implantable)?

Also how do you decide how long to retain other quality records e.g. management reviews as they are not directly linked to a product or medical device (unlike testing records, Device Master Record etc)?

Do you just assign them the same default retention period of 5 years as stated in the MDD?

Apologies for all the questions!

 

[Jean_B]

Non-directly linked very safe bet is 15 years, but I've commonly set them safely at 7 years to cover certification periods that external parties might want to look back on. It remains highly dependent on product design aging and other factors though.

IVD is unknown to me.
Core questions:

• Is my device special in any region, due to which i face special rules? (Japan; implantables)
• What is my certification period? (and at least double that)
• Did I specify (explicitly) or record (usually implicitly) a expected/projected useful/designed/service life? (This is different from warranty or guarantee period!)

Short overview (researched end of 2017) without sources (those manufacturers that would source, can source it themselves, just being efficient)

• EU MDR: at least ten (10) years (fifteen (15) for implantables) after placing last device on the market (watch your blue guide here due to definition).
• EU MDD: at least five (5) years (fifteen (15) for implantables) after placing last device on the market (watch your blue guide here due to definition).
• Brazil: Equivalent to shelf life, or at least 2 years (counting from date of distribution) for products without shelf life.
• USA: For the designed & expected life, or at least 2 years (counting from date of commercial distribution) for products without shelf life.
• Canada: For the designed & projected useful life, or at least 2 years (counting from date of distribution) for products without shelf life.
• Australia: at least five (5) years after last medical device was manufactured (to which that QMS was applied).
• China: specified service life + 5 years (counting from the moment service life starts)
• Japan (a complex one with designations, do your own research/verification with your MAH): Equivalent to shelf life, or at least five (5) years, except when products with specially designated maintenance control required medical devices, then fifteen (15) years. When shelf life exceeds either of these, then shelf life + 1 year.

EU Blue guide: ‘Blue Guide’ on the implementation of EU product rules - Internal Market, Industry, Entrepreneurship and SMEs - European Commission

 

[indubioush]

From ISO 13485:2016:
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.

If your device lifetime is 10 years, you need to retain your records for at least 10 years. In that case though, it is safer to just make it 15.
This requirement encompasses all quality system records.
You can maintain records electronically. You just have to show that the software you use for this is validated for its intended use.

 

[NikkiQSM]

Agreed with indubioush.

Our organization defines the life-time of the product to be 10 years or unless agreed upon with the customer, in writing.

 

[Ed Panek]

I recommend storing them for as long as space permits. If an auditor wants to dig through files from the past 15 years to find a violation that's their prerogative. OK sarcasm off.