GW, by “roll out plans” you’re referring to Post Market Surveillance Plan (PMS) and Post Market Clinical Follow -up (PMCF) requested by the regulatory body? Considering this particular area of CE marking legislation is one that is being strengthened as part of the new EU regulations that become binding in May this year (after being passed as law in 2017), it seems justified that they are making sure companies adhere to this ‘new framework’ and it would seem reasonable that a major part of OSL’s delay in obtaining CE mark could be tied up here. This has been posted before but here it is again.
The product being an implantable nuclear medical device therefore by nature fraught with complexities in addition to the fact that the dire consequences of PC see most patients expiring before the desired time duration of patient data gathering that these regulators require to approve any new device could also be contributing factors.
I found this article to be a useful comparison when relating some of the issues OSL have been encountering.
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