{"id":2065,"date":"2025-05-11T18:15:59","date_gmt":"2025-05-11T17:15:59","guid":{"rendered":"https:\/\/verifica.com.ua\/?page_id=2065"},"modified":"2025-05-11T22:26:31","modified_gmt":"2025-05-11T21:26:31","slug":"ocinka-vidpovidnosti-mv","status":"publish","type":"page","link":"https:\/\/verifica.com.ua\/en\/ocinka-vidpovidnosti-mv\/","title":{"rendered":"Conformity assessment of the MOU"},"content":{"rendered":"
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\u041e\u0420\u0413\u0410\u041d \u041e\u0426\u0406\u041d\u041a\u0418 \u0412\u0406\u0414\u041f\u041e\u0412\u0406\u0414\u041d\u041e\u0421\u0422\u0406 \u0422\u0415\u0425\u041d\u0406\u0427\u041d\u0418\u041c \u0420\u0415\u0413\u041b\u0410\u041c\u0415\u041d\u0422\u0410\u041c \u041c\u0415\u0414\u0418\u0427\u041d\u0418\u0425 \u0412\u0418\u0420\u041e\u0411\u0406\u0412<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t
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Definition of the CF class:<\/h3>\r\n <\/div>\r\n
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Before starting the certification process, the manufacturer must determine whether the product is a medical device or an auxiliary product to such a medical device, as well as the medical purpose and intended use.<\/p>\n

Criteria and principles of classification of medical devices are determined by Annex 2 of the Technical Regulation on Medical Devices<\/em><\/strong>approved by the CMU Resolution No. 753 dated 02.10.2013.<\/p>\n

Medical device<\/u><\/em> - is any instrument, apparatus, device, device, software, material or other product intended for the diagnosis, treatment, prevention of the human body and (or) ensuring such processes<\/p>\n

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The following types of medical devices are distinguished by their safety level:<\/h3>\r\n <\/div>\r\n
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class I<\/div>\r\n

- low risk share;<\/p>\n<\/div>\r\n <\/div>\r\n

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class IIa <\/div>\r\n

- average risk share;<\/p>\n<\/div>\r\n <\/div>\r\n

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class IIb <\/div>\r\n

- Increased share of risk;<\/p>\n<\/div>\r\n <\/div>\r\n

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class III<\/div>\r\n

- high risk share.<\/p>\n<\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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In addition, <\/em>All medical devices are classified according to the following criteria: invasiveness<\/strong> (non-invasive<\/u><\/em>\u00a0(medical devices and equipment that do not require penetration into the human body for diagnosis, monitoring or treatment),\u00a0invasive<\/u><\/em>\u00a0(fully or partially introduced into the human body through its surface or body opening), durations<\/strong> use (temporary<\/u><\/em>\u00a0(for continuous use up to 60 minutes),\u00a0short-term<\/u><\/em>\u00a0(for continuous use for up to 30 days) and\u00a0long-term<\/u><\/em>\u00a0(for continuous use for a period of 30 days or more), \u00a0availability of contact <\/strong>(contact, non-contact)<\/u><\/em> with the human body, by action<\/strong> on vital human organs, as well as the possibility of use of energy sources<\/strong> together with the product.<\/p>\n

Regardless of the class, medical devices must meet the basic requirements, including the provision of information to be supplied by the manufacturer, be subject to reporting requirements under the medical device control system and be labelled with a conformity mark.<\/p>\n

The manufacturer of medical devices or a person authorised by the manufacturer may independently determine the class of medical device, if necessary, the conformity assessment body (CAB) or (the Ministry of Health of Ukraine) confirms the correctness of determining the class of medical device.<\/p>\n

Confirmation letter<\/u><\/em> risk class from VERIFICA LLC is an official response from the authorised body (after receiving NAAU accreditation<\/u><\/strong>) on conformity assessment on the belonging of a medical device to a particular class.<\/p>\n

The specialists and experts of VERIFICA LLC will prepare a letter of confirmation of the class of medical devices at your request within a short time.<\/p>\n

Self-declaration<\/u><\/em> - is a separate independent internal control procedure for the production of medical devices, through which the manufacturer or its authorised representative ensures and confirms the compliance of medical devices with the requirements of the Technical Regulations.<\/p>\n

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Self-declaration applies to:<\/h3>\r\n <\/div>\r\n
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Medical devices of the first class (without measuring functions and not sterile), according to the Cabinet of Ministers of Ukraine No. 753;<\/p>\n<\/div>\r\n <\/div>\r\n

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Reagents, analysers, controls and calibrators that are not intended for self-monitoring and are not included in Lists A and B of the Technical Regulations on Medical Devices for In-Vitro Diagnostics, according to the Resolution of the Cabinet of Ministers of Ukraine No. 754<\/p>\n<\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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For more information about our capabilities and to arrange cooperation, please contact us at +380 (98) 281 08 28, info@verifica.com.ua<\/a> or fill in mould<\/a>.<\/p>\n

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<\/p>\n<\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

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