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  • 1.  UKCA for MDD devices

    Posted 28-Feb-2023 04:14

    Dear all, I come back to the subject due to updates from MHRA. Among the points in the document " Regulatory Horizons Council report on medical devices: government response", I read the following:

    Devices that are CE marked under EU legislation will be permitted similar transition timescales and these will run from 1 July 2024, when the new regime is planned to come into effect. For devices CE marked under the EU directives (former EU legislation), these timescales will be 5 years for IVD medical devices and 3 years for other medical devices, or until their certifications have expired, whichever is sooner. 

    My interpretation is that since we have our MDs registered in UK already, we can keep selling our MDs in UK until June 2027, due to the prolongment of the CE certificate validity by EC Regulation. 

    Is this correct, or am I reading this wrong (English is not my mother tongue)?

    Thank you



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    Christian Micheletti
    Project Manager; Regulatory Affairs expert
    Goldach
    Switzerland
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  • 2.  RE: UKCA for MDD devices

    Posted 01-Mar-2023 10:48
    Edited by Sydney O'Connell 01-Mar-2023 10:49

    Hello Christian,

    Three years (i.e., July 2027) is correct for MDD/AIMDD CE Marked medical devices. 

    The MHRA will allow 5 years for MDR CE Marked medical devices, however, as well as IVDD/IVDR CE Marked Devices. The 5-year allowance period includes if the device is MDR CE Marked after the new UK regulations take effect. i.e., if your MDD CE Marking certificate expires next year and you obtain MDR CE Marking in the meantime, then you would have until July 2029 to transition to UKCA marking. 

    • the government intends to introduce the transitional arrangements… for general medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Directive, the EU Active Implantable Medical Device Directive or the EU in vitro Diagnostic Medical Devices Directive before the regulations take effect. The government would like to establish a transitionary arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years (for general medical devices) and five years (for IVDs) after the new regulations take effect, whichever is sooner.

    • the government intends to introduce the transitional arrangements general medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Regulation or the EU in vitro Diagnostic Medical Devices Regulation. The government would like to establish a transitionary arrangement for these products which will allow products to continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect.



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    Sydney O'Connell
    Director of Global Representation
    www.casusconsulting.com
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    Original Message


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