{"id":19487,"date":"2021-10-26T09:30:10","date_gmt":"2021-10-26T07:30:10","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=19487"},"modified":"2023-01-25T17:04:29","modified_gmt":"2023-01-25T16:04:29","slug":"online-eudamed-modules-udi-devices-notified-bodies-certificates","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/10\/26\/online-eudamed-modules-udi-devices-notified-bodies-certificates\/","title":{"rendered":"EUDAMED: \u201cUDI\/ devices registration\u201d and \u201cNotified Bodies and certificates\u201d modules have been published"},"content":{"rendered":"\r\n

At the beginning of October 2021 in the EUDAMED database<\/strong> section of the European Commission website, two new modules<\/strong> have been published: \u201cUDI\/devices registration\u201d <\/strong>and \u201cNotified Bodies and certificates\u201d.<\/strong><\/p>\r\n\r\n\r\n\r\n

\"EUDAMED\r\n
\u201cUDI\/ devices registration\u201d and \u201cNotified Bodies and certificates\u201d
EUDAMED modules have been published<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n

EUDAMED database<\/strong><\/h2>\r\n\r\n\r\n\r\n

The creation of EUDAMED<\/strong> represents one of the most relevant aspects<\/strong> of the MDR (UE) 2017\/745<\/strong> and IVDR (UE) 2017\/746<\/strong> Regulations. This system is not, indeed, only developed to categorise medical devices<\/strong> and IVDs<\/strong>, but also a useful tool to supervise the lifecycle of each device<\/strong>, enhance transparency<\/strong>, and the coordination of information<\/strong> on medical devices and IVDs available on the EU market.<\/p>\r\n\r\n\r\n\r\n

EUDAMED consists of a multipurpose informatic system made up by six different modules needed for specific activities:<\/strong><\/p>\r\n\r\n\r\n\r\n

    \r\n
  1. Economic operators\u2019 registration (\u201cActor registration module\u201d) available from December 1st<\/sup>, 2020. For further information concerning this module, read our article<\/a>.<\/li>\r\n
  2. UDI\/ Devices registration.<\/li>\r\n
  3. Notified Bodies and Certificates.<\/li>\r\n
  4. Clinical Investigations and performance studies.<\/li>\r\n
  5. Vigilance and post-market surveillance.<\/li>\r\n
  6. Market Surveillance.<\/li>\r\n<\/ol>\r\n\r\n\r\n\r\n

    \u201cUDI\/ devices registration\u201d and \u201cNotified Bodies and certificates\u201d module<\/strong><\/h2>\r\n\r\n\r\n\r\n

    Besides the Actor registration module, EUDAMED second and third module, the \u201cUDI\/ devices registration\u201d and the \u201cNotified Bodies and certificates\u201d<\/strong>, are now also available.<\/p>\r\n\r\n\r\n\r\n

    In the UDI\/ devices Registration module<\/strong> it\u2019s possible to look for UDI-DI<\/strong>, and information about medical devices <\/strong>and IVDs<\/strong>. In order to launch the research, several information is required, such as manufacture\u2019s name, Actor ID\/SRN, application field, device type, and devices risk class.<\/p>\r\n\r\n\r\n\r\n

    The Notified Bodies (ON) and certificates module<\/strong> allows to look up which ONs have already been recognised and registered on NANDO (Notified Bodies database), what kind of certificates have been issued and if they are still valid.<\/p>\r\n\r\n\r\n\r\n

    Do you need assistance or further information on EUDAMED database?<\/strong><\/h2>\r\n\r\n\r\n\r\n

    Thema can give you the right support<\/strong> thanks to its team of experts.<\/p>\r\n\r\n\r\n\r\n

    It is known that EUDAMED will be fully operative only once the entire system and its various modules will be totally functional. After providing the first three modules, it will be necessary to wait for the publication of the three remaining ones (Clinical Investigations and Performance Studies, Vigilance and post-market surveillance and Market Surveillance).<\/p>\r\n\r\n\r\n\r\n

    Despite EUDAMED\u2019s delay<\/strong>, it is recommended to take steps because the procedures and activities to be carried out require a certain amount of time and energy.<\/p>\r\n\r\n\r\n\r\n

    For this reason, if you are an Economic Operator<\/strong> (EU and non-EU Manufacturer, Authorised Representative, system manufacturer, and medical devices and in-vitro diagnostic medical devices importer) Thema can support you in all strategic activities needed to comply with MDR (EU) 2017\/745 and IVDR (EU) 2017\/746 including registering in<\/strong> EUDAMED <\/strong>and notifying to the Ministry of Health of the member State that will issues the SRN code (Single Registration Number) upon the activation of the authorisation.<\/p>\r\n\r\n\r\n\r\n

    For further information, visit the Italian and European ministerial registrations<\/a><\/strong> page to find out how we can help you or contact us<\/a>!<\/strong><\/p>\r\n\r\n\r\n\r\n

    Source:<\/em><\/p>\r\n\r\n\r\n\r\n

    EUDAMED – European Database on Medical Devices, sito Commissione Europea, ottobre 2021 <\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"

    At the beginning of October 2021 in the EUDAMED database section of the European Commission website, two new modules have been […]<\/p>\n","protected":false},"author":1,"featured_media":22238,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-19487","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"\nOnline EUDAMED modules UDI\/devices and Notified Bodies\/certificates<\/title>\n<meta name=\"description\" content=\"EUDAMED modules "Registration UDI\/devices" and "Notified and certified Bodies" for Medical Devices and IVDs were published at the beginning of October 2021\" \/>\n<meta name=\"robots\" content=\"index, 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