ISO 13485 Records Retention Requirements

[amjadrana]

I am trying to establish retention time for quality records that would satisfy European, Canadian and FDA regulations.

What would be the maximum retention time to meet all regulatory requirements.

Thanks for your inputs.

 

[rose24m03]

record retention

Here are the regulatory requirements:

MDD (Annex II # 6.1) - at least 5 years after last product has been manufactured

Canada (Canadian Medical Device Regulation) # 55 - distribution records shall be maintained for the longer of (a) projected useful life of device and (b) 2 years after the date the device is shipped

US (QSR 820.180(b)) - records required shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution


Here are the questions you need to answer:

(1) what is the the life of the device? you need to define it, document it, and provide justification/rationale on how you come to this "magic number"

(2) from the life of device you have defined, what is the record retention period for quality records (e.g. SOPs, DHR, DHF, DMR, technical file/essential requirements, records, management reviews, internal audits, supplier files, audit reports and other communications from/to ISO registrars, complaints, C&R, MDRs, vigilance reports, etc)?


Some registrars recommended device life + 5 years. However, you need to define it to your devices besides meeting regulatory requirements.

 

[amjadrana]

Thanks for the help.

So the best retention time would be 10 years retention period, if the life time of product is 5 years. This would cover most of the regulations.

 

[rose24m03]

record retention

not really

MDD (Annex II # 6.1) - at least 5 years after last product has been manufactured

example: device life for Device A is 5 years

last lot #55555 manufactured in 2004, released in 2005, shipped in 2006
lot # 33333 for Device A was manufactured in 2000 and shipped in 2000
lot # 1 of Device A was manufactured in 1990 and shipped in 1990

so, records need to be kept for how long?
lot # 1: 1995 for FDA; 1995 for Canada; 2010 for MDD
lot # 33333: 2005 for FDA; 2005 for Canada; 2010 for MDD
lot # 55555: 2010 for FDA; 2011 for Canada; 2010 for MDD



hope this makes sense

 

[amjadrana]

Record retention requirements

Thank you. Yes, it helps.

I have another question related to the same problem. How can engineering determine life time of the product? Our registrar has just given us a nonconformity, because we do not have a document that can justify 5 years.

Is there a testing organization, that can test our product and tell us about life time of our product?

I do not know whether this would need another thread. Maybe some one else from electronic products industry can answer this question.

Thanks a lot for your inputs.

 

[Al Rosen]

Thank you. Yes, it helps.

I have another question related to the same problem. How can engineering determine life time of the product? Our registrar has just given us a nonconformity, because we do not have a document that can justify 5 years.

Is there a testing organization, that can test our product and tell us about life time of our product?

I do not know whether this would need another thread. Maybe some one else from electronic products industry can answer this question.

Thanks a lot for your inputs.

The answer is yes, a reliability engineer or an engineer familiar with relibility predictions can determine the lifetime. Google Bathtub Curve.

As far as the auditor is concerned, I would argue that 5 years is the point after which your organization no longer guarantees that it will have parts to service the device. There is no requirement to justify it, just to state it.

 

[rose24m03]

FDA has defined expected life of a device as....

from http://www.devicelink.com/mddi/archive/96/10/012c.html

FDA has defined expected life of a device as "the time that a device is expected to remain functional after it is placed in use." How to calculate the expected life of a device has not been defined, but presumably companies will do so based on their experience marketing the device.

from http://www.devicelink.com/mddi/archive/96/05/015.html

Among the proposals in this version that drew the most fire from industry were the application of GMPs to component manufacturers and use of the term end of life, which was intended to differentiate between servicing and reconditioning. FDA agreed to delete most, but not all, of the objectionable requirements during an August 1995 FDA-industry meeting and the GMP Advisory Committee meeting in September 1995. The end-of-life concept was deleted from the GMPs but was retained in the medical device reporting regulation.

 

[rose24m03]

Lifetime of the Device

amjadrana, please see ISO/TR 14969:2004 page 24 (section 7.1.3) for details in regards to the lifetime of the medical device. Per this guidance section, "Organizations are required by ISO 13485 to define the lifetime of the medical device for document and record control purposes. Medical device lifetime may be based on technical, legal, commercial or other considerations. The basis of the defined lifetime of the medical device should be documented."

Regulatory requirements on defining lifetime of the medical device are indirectly governed by the record retension clauses, for examples:
820.180
ISO 13485 clause 4.2.4
MDD and CMDR recordkeeping requirements on technical files, distribution records, etc.


Hope this helps.

 

[welshery]

Retention period for quality records

Dear All, I have just been reviewing the posts here relating to retention times for quality records and I am still having a little difficulty in trying to define them. Can someone please tell me, although the periods are well defined in the standards etc., If you have a product that is going to be implanted and can last up to 20 + years in the human body, does this mean that we have to keep our records for longer than that period of time? Could we say a definitive 30 years period knowing that the product certainly wont last that long inside a patient just to be on the safe side? The other issue with this is, if we do say 30 years and lets just say a lot of the information is on paper. That is a huge amount of paper to store and keep safe without deterioration. And finally, to really put the spanner in the works, what if the company is sold off and the recipient business does not accept responsibility for previous products sold and implanted, it just accepts current stock and product that was implanted after the sale date. What then happens to all the previous stored quality documentation. OK, thats enough of a headache for now. Help would be much appreciated or even your thoughts on the issue.

 

[Al Rosen]

Dear All, I have just been reviewing the posts here relating to retention times for quality records and I am still having a little difficulty in trying to define them. Can someone please tell me, although the periods are well defined in the standards etc., If you have a product that is going to be implanted and can last up to 20 + years in the human body, does this mean that we have to keep our records for longer than that period of time?

Yes, you must.

Could we say a definitive 30 years period knowing that the product certainly wont last that long inside a patient just to be on the safe side?

I don't see why not.

The other issue with this is, if we do say 30 years and lets just say a lot of the information is on paper. That is a huge amount of paper to store and keep safe without deterioration.

Yes, it is, but you have to do it.

And finally, to really put the spanner in the works, what if the company is sold off and the recipient business does not accept responsibility for previous products sold and implanted, it just accepts current stock and product that was implanted after the sale date. What then happens to all the previous stored quality documentation.

I don't know the answer to that one, but I think someone must take responsibility. Perhaps you should cross that bridge when you get to it.