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