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    UK Responsible Person

    United Kingdom’s Medicines and Health Care products Regulatory Agency (MHRA) On 18 September 2019, published new guidelines regarding the role and responsibilities of the “UK Responsible Person” to regulate medical devices after Brexit.

     

    The UK Responsible Person would be the UK equivalent of the EU Authorized Representative the role of which will then disappear with regards to the UK.

    UK Responsible Person

    Selection of UK Responsible Person

    I3CGLOBAL are experts in Medical Device Regulation for US FDA, EU MDR, UKCA, KSFDA for many years, serving thousands of clients across the globe for any class and type of medical device making us the best among other firms.

    • Experienced consultants, regulatory experts and auditors who can study and understand any type of complicated device regulation and can provide expert opinion and advice.
    • Not limited to UK Responsible person service, we provide A to Z services for Certification and compliances.
    • Friendly team for business relationships
    • Multiple payment options from multiple countries.
    • Identification of appropriate GMDN code for no charges

    From 1 January 2021, the name and address of the UK Responsible Person, where applicable, will need to be included on product labeling where the UKCA mark has been affixed. UK Responsible Person details will not need to be included in the labeling for CE marked devices.

    Responsibilities of UK Responsible Person

    The responsibilities of the UK Responsible Person are detailed in UK MDR 2019,

    • ensuring manufacturer has considered appropriate conformity assessment procedure relevant to the device class
    • assure manufacturer maintains the declaration of conformity and technical documentation.
    • maintain a copy of the technical documentation and if applicable, a copy of the relevant certificate, for inspection by the MHRA
    • providing the MHRA with all the information and documentation necessary on request
    • coordinate with the manufacturer any request by the MHRA for samples or access to a device.
    • cooperating with the MHRA on any preventive or corrective action taken to eliminate potential risks
    • Inform manufacturer about incidents & complaints in the shortest period.
    • monitor manufacturer, if acts contrary to its obligations under these Regulations and informing the MHRA and if required terminate the relationship with the manufacturer and inform Notified body.
    • opening a single registration account on behalf of the manufacturers that it represents.
    • support PMS activities

    REGISTRATION IN GREAT BRITAIN / MHRA REGISTRATION

     

    Non-UK manufacturers after appointing their UK Responsible Persons, after the transition period, any medical device (any class), IVD, or custom made device will need to be registered with the MHRA before being placed on UK Market.

     

    The MHRA registration is possible only if the manufacturer or their UK Responsible Person has a registered place of business in the UK.

     

    The following devices must be registered with the MHRA before 1 May 2021 for marketing in the UK

     

    The following devices must be registered with the MHRA before 1 September 2021 for marketing in the UK

    • Class IIb non-implantable medical devices
    • Class IIa medical devices
    • IVD List B products
    • Self-test IVDs

     

    The following devices must be registered with the MHRA before 1 January 2022 for marketing in the UK

    • Class I medical devices
    • General IVDs

     

    We can help manufactures complete MHRA Registration ahead of the above dates, but there will be no legal obligation to do so.

    MHRA REGISTRATION RENEWAL

    MHRA Registration must be renewed one year after your registration application or confirmation was made and every two years after this date. Failure to renew your registration will result in the removal of your records from our database, after which you will need to complete a new registration application or you will no longer be able to place your device on the UK market.

     

    Check Medical Device MHRA Registration status >>>

    ANNUAL UK REP & MHRA REGISTRATION FEES

    Annual UK Responsible person service fees for the various classes as follows.

     

    Class I: 850 GB
    Class Is / r/ m: 1000 GB
    Class IIa: 1100 GB
    Class IIb: 1200 GB
    Class III: 1300 GB

     

    MHRA Registration fees per GMDN Code / DOC / Intended Use

     

    1200 GB for 3 years
    900 GB for 2 years
    600 GB for 1 year ( Yearly renewal charges 300 GB)
    (above fees includes administrative fees)