{"id":52824,"date":"2023-02-24T18:08:51","date_gmt":"2023-02-24T12:38:51","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=52824"},"modified":"2023-02-24T18:08:54","modified_gmt":"2023-02-24T12:38:54","slug":"ukca-mark-for-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/ukca-mark-for-medical-devices\/","title":{"rendered":"UKCA Mark for Medical Devices – An Overview"},"content":{"rendered":"\n

On January 31,\n2020, the UK formally left the EU. The post-Brexit transition period ended on\nJanuary 1, 2021. Medical device firms with products in the UK market now need\nto plan for how they will obtain a UK Conformity Assessment. Medical devices\nnow sold in the UK can continue displaying the CE mark, which has been a requirement\nunder EU law since 1985. (UKCA mark). On July 1, 2023, the UKCA mark is scheduled to become\nlaw, enabling medtech manufacturers two more years to comply. But, having more\ntime to comply doesn’t guarantee that every business will be prepared when the\ntime comes, as evidenced by the frequent delays to the EU’s Medical Device\nRegulation. Until\u202fJune 30,\n2023, devices can still be marketed in the UK under the CE mark. But, starting\non July 1st, all medical devices and in vitro diagnostics (IVDs) must bear the\nUKCA mark to be sold. The only exceptions to this rule are medical equipment\nmade by Northern Ireland\u202fmanufacturers, who will be permitted to continue\nmarketing CE-marked products in the UK after the deadline. Already, compliance\nis necessary for some devices. To ensure that their devices may still be sold\nafter the 2023 deadline, manufacturers will need to take several actions.  In this\nblog, we will discuss, UKCA marking for medical devices.<\/p>\n\n\n\n

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