{"id":1741,"date":"2022-12-09T05:33:59","date_gmt":"2022-12-09T05:33:59","guid":{"rendered":"https:\/\/operonstrategist.com\/southafrica\/?page_id=1741"},"modified":"2025-03-27T08:23:45","modified_gmt":"2025-03-27T08:23:45","slug":"ukca-marking","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-za\/services\/regulatory-approvals\/ukca-marking\/","title":{"rendered":"UKCA Marking"},"content":{"rendered":"\t\t
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\nUnderstanding UKCA Marking & UK Regulatory Process<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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MHRA has currently published new guidance on rules that will govern the regulation of medical devices. Here\u2019s a quick overview that can help you to know about the post-Brexit medical device regulatory changes for marketing medical devices in the UK market. With a regular demand for imported products, the industry–in addition to the regulatory devices–is receptive to novel and revolutionary technology, which creates huge opportunities for medical device manufacturers in the market. <\/span><\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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MHRA Registration and UKCA Marking<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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MHRA (<\/span>The Medicines and Healthcare Products Regulatory Agency) is the medical device regulatory body for the UK medical device market. To place a medical device in Great Britain’s market key requirements are as follows: <\/span>\u00a0<\/span><\/p>

  • New product marking (UKCA mark) is available.<\/span>\u00a0<\/span><\/li>
  • Medical devices and IVDs need to be registered with MHRA before being placed on the market.<\/span>\u00a0<\/span><\/li>
  • If a manufacturer is outside of the UK, then he \/she needs to appoint a single UK-responsible person.<\/span>\u00a0<\/span><\/li>
  • CE marking will be continued till June 30, 2024.<\/span>\u00a0<\/span><\/li><\/ul>

    The medical devices in the UK are classified as <\/span>Class I, Class IIa, Class IIb, and Class III\u202f<\/span>\u00a0 the way the European Union classifies the devices. <\/span>Class I<\/span> Medical devices are low-risk devices whereas <\/span>class III\u202f<\/span>devices are high-risk medical devices.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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    Looking For Medical Device Regulatory Consultants?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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