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

Thukira

Involved In Discussions
#1
Hi all

This is regarding the “Retention Period” of Documents and Records as per ISO 13485, MDD, and also MDR.

Please review below, provide suggestion in defining the same.

ISO 13485:2016
4.2.4 Control of documents
The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable regulatory requirements.

4.2.5 Control of records
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.

EU Regulation – MDD & MDR

MDD – Existing Regulation - ANNEX VI - EC DECLARATION OF CONFORMITY (Product quality assurance)
5. Administrative provisions
5.1. ►M5 The manufacturer or his authorized representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities: ◄
— the declaration of conformity,
— the documentation referred to in the seventh indent of Section 3.1,
— the changes referred to in Section 3.4,
— the decisions and reports from the notified body as referred to in the final indent of Section 3.4 and in Sections 4.3 and 4.4,
— where appropriate, the certificate of conformity referred to in Annex III.

MDR – New Regulation - CHAPTER III ADMINISTRATIVE PROVISIONS
7. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorized representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities: — the EU declaration of conformity, — the documentation referred to in the fifth indent of Section 2.1 and in particular the data and records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2, — information on the changes referred to in Section 2.4, — the documentation referred to in Section 4.2, and — the decisions and reports from the notified body as referred to in this Annex.

Extract from post related to the same subject
Here are the regulatory requirements:

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?
for MDD
lot # 1: 2010
lot # 33333: 2010
lot # 55555: 2010


for MDR
lot # 1: 2020
lot # 33333: 2020
lot # 55555: 2020

Do we need to revise our QMS procedure – control f documents and records for this change?
 
#3
I have a similar question on this topic specifically on Production Batch Records for medical device and IVD.

FDA and ISO are both 2 years after specific batch release. What about EU MDR and IVDR?
 

yodon

Staff member
Super Moderator
#4
21 CFR 820.180 says:

(b) Record retention period. 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.
 

AGile

Registered
#6
I have the same concerns regarding the records, however the question I have is the following:

Since FDA and ISO requirements are two years and MDD is 5 years and MDR is 20 years, when retaining the records would a company go by the last manufactured product for a particular country or it doesn't matter. For example the last model for a product manufactured and sold in the US was 2005 yet for the purpose of the MDR and MDD the last product of the same model was manufactured and sold was in 2000 how long would a company have to keep those records? Is it specific to the area of the world?
 
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