MDD (Medical Device Directive) 6.1 Record Retention Requirements question

D

diagmgr25

#1
I am looking for more clarification on what records to retain to meet the MDD 6.1 requirement. We don't build an active implantable device - so I am using 5 yrs after the last product has been manufactured as the retention period.
Therefore, some types of records are very clearly to be retained for this period - DHR, DMR, Risk files, etc becuase they tie directly to the product . But others such as CAPA, Mgmt review & Internal audits (records of the quality system) don't seem to be tied to the "last product manufactured" time frame.
So my question is: What records are covered by the "5 yrs after last product manufactured" and which are not? Especially given MDD 6.1 also refers 3.1 -indent 4 Quality management system.
Can I get away with 5 year retention from date of issue for CAPA, mgmt review, etc?
confused - thansk for advice!
 
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pkost

Trusted Information Resource
#2
I am guessing that you mean 6.1 of Annex 2 of 93/42/eec, You should note that the 15 years applies to all implantable devices, not just active implantables. I've given more detail below as to what exactly is required (in bold), but essentially it means that you have to keep all quality documentation, including CAPA, mgmt review, internal audits. The 5 or 15 year time span of quality records applies to the current documentation at the time the device is placed on the market.


section 6 specifies:

The manufacturer or his authorised 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, keep at the disposal of
the national authorities:
— the declaration of conformity,
— the documentation referred to in the fourth indent of Section 3.1
and in particular the documentation, data and records referred
to in the second paragraph of Section 3.2,
— the changes referred to in Section 3.4,
— the documentation referred to in Section 4.2, and
— the decisions and reports from the notified body as referred to in
Sections 3.3, 4.3, 4.4, 5.3 and 5.4.
Section 3.1 fourth indent is:"the documentation on the quality system" i.e. the quality documentation
in particular, as referred to in Section 3.2
policies and procedures such as quality programmes, quality plans, quality manuals and quality records.
The changes in referred to in 3.4 are
substantial changes to the quality system or the product-range covered.
The documentation referred to in 4.2 describes the
design, manufacture and performances of the product in question
Additionally you must retain decisions and reports from the notified body as specified in sections:
3.3 - NB quality system audits
4.3 - NB design reviews
4.4 - changes to design
5.3 - quality system surveillance visits
5.4 - unannounced inspection visits
 
Last edited:

Michael Malis

Quite Involved in Discussions
#3
Pkost,

Thanks for the list.

I want to add a few more points of documentation that we need to keep:
1. Product recalls and decisions not to recall.
2. Rework records (not just at the manufacturing site, but also at distribution location).
3. Supplier audit records.
4. Root cause (specifically for documentation when you deviate from standard process).
5. Health Hazard Documentation evaluated by qualified personal (i.e. Medical, not QC).
 
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