Technical File Maintenance - Old generation product

[Aaria]

Hi,

My question is related to maintaining technical file for a legacy product. We have CE mark for V(x) of the medical device and now V(x.1) is in the design and development phase. We never launched V(x) but were only using the CE marked version in clinical studies.

The manufacturing of V(x) has been decommissioned last year because of which few documents such as Router/BOM were marked 'obsolete' in the change management system. Because we have an active CE mark certification, do we have to keep the supporting documents in the "approved/released" status to demonstrate an active "DMR". Typically record retention would kick in but the questions is more about "approved-relased" vs. "obsolete" status of supporting documentation to maintain the tech. file.

Sorry, for the long text, but really hoping to get some input.

Thanks!

 

[Ronen E]

Hi,

A. I'm not aware of a specific requirement to maintain the tech file documents in a specific status. the requirement / expectation is that those documents will be available for review in a reasonably timely manner (in my opinion regardless of status "active" vs. "obsolete").

B. If you don't intend to introduce V(x) any more then I would recommend contacting your NB and just notifying them that the product is discontinued. That would minimise residual requirements related to its tech file.

 

[Aaria]

Thank you for your reply and it makes sense that regardless of the document status, the tech. file can be maintained if those documents are available.

For response, B., I've a follow-up question, hypothetically, if we were to contact NB and inform that the product is now discontinued, we would lose the CE mark status as a company correct? If it were to stay active, for the next version of the product it would be a change impact assessment vs. an entire new tech. file. What are your thoughts?

Thanks!

 

[Ronen E]

For response, B., I've a follow-up question, hypothetically, if we were to contact NB and inform that the product is now discontinued, we would lose the CE mark status as a company correct? If it were to stay active, for the next version of the product it would be a change impact assessment vs. an entire new tech. file. What are your thoughts?

There's no such thing as "CE mark status" for a company. CE marking clearance (EC certificate) is granted for products. So in my understanding you can't lose "your status" as a company. In my opinion the revised device version would be assessed as an incremental change from the old, cleared version, regardless of whether the latter is discontinued or not, based on your communications with the NB. They should know that the old version has been cleared and that it wasn't discontinued due to some failure or lack of compliance, but simply due to business considerations, and therefore it's still a good baseline for the upgrade (in the regulatory sense). To be on the safe side, I recommend open communication with the NB to that extent, upfront. I estimate that they will cooperate.

Cheers,
Ronen.

 

[fialor]

Hi,

My question is related to maintaining technical file for a legacy product. We have CE mark for V(x) of the medical device and now V(x.1) is in the design and development phase. We never launched V(x) but were only using the CE marked version in clinical studies.

The manufacturing of V(x) has been decommissioned last year because of which few documents such as Router/BOM were marked 'obsolete' in the change management system. Because we have an active CE mark certification, do we have to keep the supporting documents in the "approved/released" status to demonstrate an active "DMR". Typically record retention would kick in but the questions is more about "approved-relased" vs. "obsolete" status of supporting documentation to maintain the tech. file.

Sorry, for the long text, but really hoping to get some input.

Thanks!

Aaria,
Three points are worth bearing oi mind:

1 - unless your product is a class III, the CE mark will be for either the generic product group or product family. Meaning you are able to include devices of generational increase or same focus (use, user group, function, manufacturing processes etc). This means the number of products in the group or family increases or decreases depending on what you add in or take out. When you advise your NB that you have discountinued the said product in that group, they will remove it from the relevant CE mark certificate. Some NBs actually include the products list as an annex to the certificate and will charge for revision, some do not include it.

2 - if the technical file is for both versions of the device then you would need to maintain it as it would include maintaining for the newer version of device.
If the technical files are separate, then no you do not need to maintain obsolote product's.

3 - However you would need to keep the record of the obsolete device for 10 years after the last device was placed on the market if your device falls under the remit of RoHS.

I hope this helps.