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Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirements


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Some Related Topic Tags (Not all threads are Tagged)
class ii medical device, european union, european union medical device directives (mdd), expiration date, market recalls, recall notices, recalls (general), medical devices
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  Post Number #1  
Old 23rd June 2011, 05:21 AM
Arnthor

 
 
Total Posts: 47
Please Help! Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirements

Hi everyone,

Do I need to conduct a market recall if my manufacturer had failed to print the expiry date of my medical device (class II)?

If yes, what is the recall regulatory requirements in EU?

Please advice

Arnthor

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  Post Number #2  
Old 23rd June 2011, 05:48 AM
sreenu927

 
 
Total Posts: 538
Re: Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirem

Hi,

From my view, no need to recall.

You can perform a Field Safety Corrective Action---send a FSN to Competent Authority,NB,EU REP and Customer mentioning the issue. To customer along with FSN, send the updated label or if the units are less, your own field service guyz can go paste the updated label that has expiration date.

And all it depends on the type of this class II product. Is it a reagent/kit/instrument..so based on that, u need to take decision, perform health hazard analysis/risk impact and do field safety corrective action or instruct customers to scrap (provided that you are not confident of the shelf-life validity by this time and it is NOT an instrument).

Follow the MEDDEV 2.12-1 rev 6 Guidelines on Medical device Vigilance System as attached, which requires an Incident reporting for this case.

Regards,
Sreenu
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  Post Number #3  
Old 23rd June 2011, 06:21 AM
pkost

 
 
Total Posts: 742
Re: Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirem

I think it depends on the product and the point of the expiry date. What is the risk to the patient if the product is used after it's use by? Is it possible to determine that the use by has passed without the label? what is the risk of you missing a label even with a FSN?


If the expiry is soon then there is a risk that before you could update the labels a device is used.

I suggest you contact your competent authority and get a definitive answer. Without knowing your product it is not possible to give a good answer. However, in my field with sterile medical implants, I would err towards a recall
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