{"id":16972,"date":"2021-01-05T09:30:02","date_gmt":"2021-01-05T08:30:02","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=16972"},"modified":"2026-04-01T16:50:21","modified_gmt":"2026-04-01T14:50:21","slug":"registration-medical-device-united-kingdom","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/registration-medical-device-united-kingdom\/","title":{"rendered":"Medical Device Registration in the United Kingdom"},"content":{"rendered":"
\"inghilterra\"<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

Medicines and Healthcare products Regulatory Agency (MHRA).<\/p>\n

Classification<\/strong><\/h5>\n

Class I, Class IIa, Class IIb, Class III.<\/p>\n

Quality system<\/b><\/h5>\n

ISO 13485:2016.<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n<\/div>

<\/i><\/span>The information on this page is valid and current as of April 2026. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

All devices must be registered via the MHRA DORS system before being placed on the Great Britain market. Registration requires a declaration of product conformity (marking):<\/p>\n

CE Mark (MDR\/IVDR)<\/strong>: The CE mark continues to be recognized for the registration and sale of medical devices in Great Britain during a transitional period, with differentiated deadlines for \u201clegacy\u201d devices and those certified under MDR\/IVDR, in line with the latest MHRA provisions on CE mark recognition periods.<\/p>\n

UKCA Mark<\/strong>: The UKCA mark is the reference marking for the Great Britain market and will become fully mandatory at the end of the CE mark recognition transitional periods, in line with the latest MHRA guidelines. The manufacturer may adopt the UKCA mark early if it has successfully completed conformity assessment under UK legislation, possibly with the support of a UK Approved Body.<\/p>\n

<\/p>\n

Main Registration Phases<\/span><\/h3>\n
    \n
  • Application Submission<\/strong>: The manufacturer or its UK Responsible Person enters its data, GMDN\/UDI code, and uploads certificates and necessary documents into the portal.<\/li>\n
  • Formal Verification<\/strong>: Completeness and consistency check of documentation by MHRA.<\/li>\n
  • Registration Confirmation<\/strong>: Issuance of authorization to market in Great Britain.<\/li>\n<\/ul>\n

    Applicant <\/span><\/h3>\n

    Manufacturers based outside Great Britain, including extra-EU ones, must appoint a UK Responsible Person (UKRP) based in the United Kingdom.
    The UKRP is the legal contact for registration; it registers the manufacturer, verifies technical documentation, and manages relations with MHRA for incidents and complaints.<\/p>\n

    Timelines and costs<\/span><\/h3>\n
      \n
    • Under standard conditions, registration confirmation is generally issued within a few weeks.<\/li>\n
    • Fees are set by MHRA, vary by registration type, and are due at submission and for any updates.<\/li>\n<\/ul>\n

      Certificate Validity<\/span><\/h3>\n

      No fixed expiry; must be updated in case of significant changes.<\/p>\n

      Language of Documentation and Labelling<\/span><\/h3>\n
        \n
      • Technical Documentation: English.<\/li>\n
      • Labelling and IFU (Instructions for Use): English.<\/li>\n<\/ul>\n

        Useful information<\/span><\/h3>\n
          \n
        • MHRA Website: The Medicines and Healthcare products Regulatory Agency constantly updates guidelines on CE certificate deadlines and UKCA implementation; it is the primary source for regulatory information.<\/li>\n
        • Northern Ireland: Different rules apply (Northern Ireland Protocol); CE marking remains required and MDR\/IVDR apply.<\/li>\n<\/ul>\n

          <\/p>\n

          <\/p>\n<\/div><\/div><\/div><\/div><\/div>

          <\/div><\/div>
          \n
          \n

          <\/p>

            <\/ul><\/div>\n
            \n
            \n<\/fieldset>\n

            Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n