{"id":4174,"date":"2021-05-14T12:04:48","date_gmt":"2021-05-14T10:04:48","guid":{"rendered":"https:\/\/www.entecerma.it\/the-clinical-evaluation-in-the-new-mdr-2017-745-are-you-ready\/"},"modified":"2021-05-14T12:49:38","modified_gmt":"2021-05-14T10:49:38","slug":"the-clinical-evaluation-in-the-new-mdr-2017-745-are-you-ready","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/the-clinical-evaluation-in-the-new-mdr-2017-745-are-you-ready\/","title":{"rendered":"The Clinical Evaluation in the new MDR 2017\/745: are you ready?"},"content":{"rendered":"\n

ECM organises an 8-hour training course to get a better understanding of the clinical evaluation process of medical devices in relation to the requirements of Regulation 2017\/745 (MDR).<\/em><\/strong><\/h2>\n\n

On 26 May 2021<\/strong>, the new European Regulation for Medical Devices will become applicable, introducing many new issues for manufacturers and all actors involved in the certification process.<\/p>\n\n

Clinical Evaluation<\/span><\/strong>\u00a0\u2013 i.e. that “systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer” (Art.2 point 44, <\/em>Regulation (EU) 2017\/745<\/em><\/a>) \u2013 becomes one of the key documents of the new regulation.<\/p>\n\n

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To navigate through the complexity of the new requirements, ECM Academy proposes an 8-hour online training course on 8 and 15 June.<\/u><\/strong><\/h4>\n\n
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WHO IS THE COURSE FOR?<\/span><\/strong><\/h3>\n\n

Experts in regulatory affairs, professionals in charge as Person Responsible for Regolatory Compliance (PRRC), physicians, quality and clinical experts, designers and engineers in the medical sector.<\/p>\n\n

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AIMS OF THE COURSE \n<\/span><\/strong><\/h3>\n\n

The course aims to provide participants with the essential knowledge to deal with the clinical evaluation process<\/strong> in all its aspects, identifying the key requirements of the new regulation, the steps and principles of the clinical evaluation process, how to apply and report them. MDCG guidance documents and other relevant guidelines<\/strong> will also be discussed in order to provide participants with a practical tool to address the new requirements.<\/p>\n\n

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TOPICS COVERED \n<\/span><\/strong><\/h3>\n\n