How do I determine Records Retention Time requirements? Medical Devices



Could someone tell me what the record retention period is for quality records when you are dealing with medical devices? I've heard it's seven years.


Alf Gulford


What we found is that it's up to us to define (with a minimum of 2 years, per EN 46001 and ISO 13485:1996). I don't have a copy of the European Medical Device Directive in front of me but there may be something in there that mandates a minimum of 5 years, if that's even applicable to you.

You've got to balance what's good for your business against the resources necessary for keeping tons of records, and against the marketing value of saying your product has a long life.

One way to handle it is to state that "For recordkeeping purposes" you define the life of your product as "X" years. Then explain that the number is derived from such things as your warrenty period, regulatory requirements (as noted above) and 'other requirements.' Seven years seems to be fairly common and reasonable. That's still a lot of records but medical devices carry a little heavier burden in many respects - helps keep the competition down.

Or, some consultants will simply say to confine it to your warrenty period, but I don't think that will satisfy agencies or your customers.



Involved In Discussions

21 CFR Part 820.180 covers the records retention requirements for medical devices.

"All records required by this part 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 by the manufacturer."

As Alf said, you need to know what the life of the device is and retain your records for at least that long. If you think about it, you are responsible for the proper performance of the device until it expires. If a device is used just prior to expiration and creates problems for a patient or practicioner, you will want to have all pertinent records available to show the FDA the due diligence that was performed in designing and manufacturing that device.

In our case, five years is a common lifetime for devices and we retain our records for seven years to cover its lifetime and any possible overlap in manufacturing, sales, and distribution.
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