OSL oncosil medical ltd

Let's read that BSI article carefully, it refers to existing CE...

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    Let's read that BSI article carefully, it refers to existing CE Marks already approved under BSI-UK which have to be migration prior to 30/03/2019. OSL's CE Mark has NOT been issued and therefore not in the same category!

    The Competent Authorities advise:

    a) As of 30 March 2019, the UK will become a third country and the CE certificates will lose their validity.

    b*) However, very importantly, once CE certificates lose their validity post 29 March, they will not be able to be transferred or migrated to an EU NB. Products will lose market access, and a new conformity assessment will be required.

    c) Cut off for the product will be based on whether the product is considered as having been ‘placed on the market’. 


    Today's Appendix 4C (Quarterly Report) clearly indicated that:

    • CE Mark Certification is in the final phase of internal peer review assessment as confirmed by the Notified Body, BSI, and is approaching final CE Mark decision point.

    I presume the OSL's management could not have made this announcement earlier until they have factual confirmation from BSI.
    Last edited by Medicine Man: 31/01/19
 
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