MDR - Regarding the “Retention Period” of Documents and Records

[Mrs Dean]

Hi all,
I would like to have some clarification regarding this topic. For implantable devices, it was mentioned the retention period is 15 years after the last device has been placed on the market. Moving to that:
1) Does it include the shelf life of the product itself? eg: 15 years or 15+5 years of shelf life = 20 years.
2) What are the documents in detail that need to be kept? (DoC, EC Cert, TD...)
3) Suppose the documents should be kept in hardcopy as well or softcopy is already sufficient? Any reference for this?

Thanks in advance!

 

[Ronen E]

1) Does it include the shelf life of the product itself? eg: 15 years or 15+5 years of shelf life = 20 years.

Shelf life is irrelevant here. Placing on the market (of a device unit) is a distinct legal event on the timeline, so the counting starts from it regardless. If the device sat on the shelf, say, 4.5 years before it was placed on the market, the retention time would be 19.5 years (if the device's shelf life is 5 years and it already sat on the shelf for 5 years, don't place it on the market! It's already out of date). If the device was supplied and placed on the market right away, then sat on the shelf somewhere in the EU for 4.9 years and then implanted, the retention time would still be 15 years from the placement on the market (10.1 years after implantation).

2) What are the documents in detail that need to be kept? (DoC, EC Cert, TD...)

All the above, and more.

3) Suppose the documents should be kept in hardcopy as well or softcopy is already sufficient? Any reference for this?

Either. The MDR is unspecific about this, so there is no official reference. All the MDR says is it should be kept available for the competent authorities.