{"id":17110,"date":"2021-01-25T18:15:49","date_gmt":"2021-01-25T17:15:49","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=17110"},"modified":"2023-02-14T10:30:02","modified_gmt":"2023-02-14T09:30:02","slug":"brexit-how-to-register-medical-devices-at-mhra","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/01\/25\/brexit-how-to-register-medical-devices-at-mhra\/","title":{"rendered":"BREXIT: how to register Medical Devices at MHRA"},"content":{"rendered":"

Following BREXIT, from 1 January 2021<\/strong> the United Kingdom is no longer a member of the European Union.
How to register Medical Devices now to maintain or introduce your devices on the UK market?<\/p>\n

\"brexit
How to register Medical Devices at MHRA<\/figcaption><\/figure>\n

MHRA <\/strong>published a new guide <\/strong>\u201cRegister medical devices to place on the market\u201d indicating the requirements and deadlines for registering<\/strong> Medical Devices and IVDs on the markets of Great Britain and Northern Ireland from 1 January 2021. Instead, the rules for entering <\/strong>Medical Devices and IVDs have been defined in the guide \u201cRegulating medical devices in the UK\u201d.<\/p>\n

First of all it is recalled that, from 1 January 2021<\/strong>, if the Manufacturer is based outside the UK it must appoint a UK Responsible Person (UKRP)<\/a>. <\/strong><\/p>\n

Moreover, in order to be registered with the MHRA database, the device must comply with the Medical Devices Regulations 2002 UK MDR 2002 (Northern Ireland has different registration requirements).<\/p>\n

Until 30 June 2023<\/strong> MHRA continues to recognise the CE marking<\/strong>, while from<\/strong> 1 July 2023<\/strong>, it will be necessary to meet the requirements to obtain the UKCA mark<\/strong> (UK Conformity Assessed) in order to market MDs on the UK market. In Northern Ireland, instead, different requirements apply for the CE marking and the UKNI mark<\/strong>, which is the new mark of conformity for products placed in Northern Ireland.<\/p>\n

According to the new guide, different Period of Grace<\/em> are provided for the registration of MDs and IVDs according to their risk class.<\/p>\n

Period of Grace<\/em><\/strong> for the registration of Medical Devices at MHRA<\/strong><\/h2>\n

In accordance with the new regulations in force from 1 January 2021 and to meet the registration requirements at MHRA, Period of Grace<\/em> (different by class and type of device) are provided to confirm\/modify the data already present in case of Manufacturer\/AR located outside the UK<\/strong>.<\/p>\n

To be registered by 1 May 2021:<\/strong><\/p>\n