{"id":2891350,"date":"2023-09-20T16:11:12","date_gmt":"2023-09-20T20:11:12","guid":{"rendered":"https:\/\/wordpress-1016567-4521551.cloudwaysapps.com\/plato-data\/mhra-guidance-on-ivd-regulations-conformity-assessment-basics-regdesk\/"},"modified":"2023-09-20T16:11:12","modified_gmt":"2023-09-20T20:11:12","slug":"mhra-guidance-on-ivd-regulations-conformity-assessment-basics-regdesk","status":"publish","type":"station","link":"https:\/\/platodata.io\/plato-data\/mhra-guidance-on-ivd-regulations-conformity-assessment-basics-regdesk\/","title":{"rendered":"MHRA Guidance on IVD Regulations: Conformity Assessment Basics – RegDesk"},"content":{"rendered":"
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The new article addresses the aspects related to the conformity assessment procedures in vitro diagnostic medical devices should undergo in order to ensure their safety and proper performance. <\/span><\/p>\n<\/div><\/div>\n

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<\/span>Table of Contents<\/span><\/h2>\n<\/div><\/div>\n

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The Medicines and Healthcare Products Regulatory Agency (<\/span>MHRA<\/a><\/strong>), <\/strong><\/span>the UK regulating authority in the sphere of healthcare products, has published a guidance document<\/a> dedicated to in vitro diagnostic (IVD) medical devices and the regulatory status thereof. In particular, the document provides an overview of the applicable regulatory requirements, as well as additional clarifications to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. <\/span><\/p>\n

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. <\/p>\n

The scope of the guidance covers, inter alia, the aspects related to the conformity assessment IVD products should undergo in order to ensure safety and proper performance, as well as compliance with any and all applicable regulatory requirements such products are subject to in accordance with the existing legal framework. <\/span><\/p>\n<\/div><\/div>\n

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<\/span>Conformity Assessment Process: Key Points <\/span><\/span><\/h2>\n

As explained by the authority, the parties responsible for IVD devices (medical device manufacturers), before placing their product on the market, should:<\/span><\/p>\n