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href="https://health.ec.europa.eu/document/download/3518b8dc-238a-4844-9f80-27aced75173a_en?filename=md_generic_fs_en.pdf">New rules to ensure safety of medical devices</a></td><td class="ecl-table__cell"><a href="https://health.ec.europa.eu/document/download/d7eeed24-f158-4044-8f2c-1c6fee9f67ef_en?filename=md_infographic-new-reg_en.pdf">Infographics; "New Regulations" (IVDR and MDR)</a> <br>(available in all EU languages and <a href="https://health.ec.europa.eu/document/download/d7eeed24-f158-4044-8f2c-1c6fee9f67ef_en?filename=md_infographic-new-reg_en.pdf">Arabic</a>, <a href="https://health.ec.europa.eu/document/download/7da3603e-01de-4f8f-bfe8-d87faa6a1437_en?filename=md_infographic-new-reg_zh.pdf">Chinese</a>, <a href="https://health.ec.europa.eu/document/download/06b6f706-ebcb-430e-beee-64b320000b82_en?filename=md_infographic-new-reg_ja.pdf">Japanese</a>, <a href="https://health.ec.europa.eu/document/download/f6b86b29-7e42-4873-80a3-de93626c646f_en?filename=md_infographic-new-reg_ru.pdf">Russian</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="What is your area of activity?"><p><a href="https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf">MDR transition periods</a></p><p>IVDR transition periods (visual coming soon)</p></td><td class="ecl-table__cell"><a href="https://health.ec.europa.eu/document/download/0f868301-8580-48e8-afa1-79aae839188e_en?filename=thirdcountries_factsheet_en_0.pdf">Competent authorities in non-EU/EEA countries</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="What is your area of activity?"><a href="https://health.ec.europa.eu/document/download/6c636d24-e6cd-49c9-ac8e-6e215a9cce25_en?filename=procurementecosystem_factsheet_en.pdf">The Procurement of MDS and IVDS</a></td><td class="ecl-table__cell"><a href="https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices/healthcare-professionals-and-health-institutions_en">Healthcare professionals and health institutions</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="What is your area of activity?"><a href="https://health.ec.europa.eu/document/download/88eff4e3-9763-435e-a3b9-75aadfc8df65_en?filename=md_manufacturers_factsheet_en.pdf">Manufacturers of medical devices</a><br><a href="https://health.ec.europa.eu/document/download/d7dded29-984b-4df7-bf6f-11d9af19097f_en?filename=md_manufacturers_factsheet_annex_en.pdf">+ Step by Step guide</a></td><td class="ecl-table__cell"><a href="https://health.ec.europa.eu/document/download/82c113e2-7876-4405-9f5f-b2799c2f6a25_en?filename=ivd_manufacturers_factsheet_en.pdf">Manufacturers of in vitro diagnostic medical devices</a><br><a href="https://health.ec.europa.eu/document/download/3f4f0cfd-fbcd-47e8-9282-193805b5f035_en?filename=ivd_manufacturers_factsheet_annex_en.pdf">+ Step by Step guide</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="What is your area of activity?"><a href="https://health.ec.europa.eu/document/download/37879254-c7d6-487b-8fd9-06496e771465_en?filename=importersdistributors_factsheet_en.pdf">Authorised representatives, importers and distributers</a></td><td class="ecl-table__cell"><a href="https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices/manufacturers-devices-without-intended-medical-purpose_en">Manufacturers of devices without an intended medical purpose</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="What is your area of activity?"><a href="https://health.ec.europa.eu/document/download/b865d8e9-081a-4601-a91a-f120321c0491_en?filename=md_mdcg_2021_mdsw_en.pdf">Is your software a medical device?</a></td><td class="ecl-table__cell"><a href="https://health.ec.europa.eu/document/download/add107c5-0ca8-45d3-b049-63bb84c4ce31_en?filename=md_faq_udi_en.pdf">Unique Device Identifier - UDI</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="What is your area of activity?"><a href="https://health.ec.europa.eu/document/download/e724bca0-7035-426e-9672-bd2404ebb6a7_en?filename=md_q-a_emdn_en.pdf">European Medical Device Nomenclature – EMDN Q&A</a></td><td class="ecl-table__cell"> </td></tr></tbody></table></div></div> </div> </article> </div> <div data-inpage-navigation-source-area="h2"> <div id="block-mdnewregulationsblock"> <div class="ecl-u-mb-2xl"> <a id="paragraph_56"></a> <div id="block-mdnewregulationslatestupdates" class="ecl-u-mt-l"> <div class="ecl-content-item-block"><div class="ecl-row"><div class="ecl-content-item-block__title ecl-col-12"><h2 class='ecl-u-type-heading-2'>Latest updates</h2></div></div><div 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href="/latest-updates/mdcg-2023-3-rev1-questions-and-answers-vigilance-terms-and-concepts-outlined-regulation-eu-2017745-2024-11-11_en" class="ecl-link ecl-link--standalone" >MDCG 2023-3 rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - November 2024</a></div><ul class="ecl-content-block__secondary-meta-container"><li class="ecl-content-block__secondary-meta-item"><svg class="ecl-icon ecl-icon--s ecl-content-block__secondary-meta-icon" focusable="false" aria-hidden="true" ><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#clock"></use></svg><span class="ecl-content-block__secondary-meta-label">1 min read</span></li></ul></div></div></article></div><div class="ecl-content-item-block__item contextual-region ecl-u-mb-l ecl-col-12 ecl-col-l-6 last-item-column"><article class="ecl-card" ><div class="ecl-card__body"><div class="ecl-content-block ecl-card__content-block" data-ecl-auto-init="ContentBlock" data-ecl-content-block ><ul class="ecl-content-block__primary-meta-container"><li class="ecl-content-block__primary-meta-item">News announcement</li><li class="ecl-content-block__primary-meta-item"><time datetime="2024-07-26T12:00:00Z">26 July 2024</time></li></ul><div class="ecl-content-block__title"data-ecl-title-link><a href="/latest-updates/template-notified-body-confirmation-letter-status-formal-application-written-agreement-and-2024-07-26_en" class="ecl-link ecl-link--standalone" >Template for notified body confirmation letter of the status of a formal application, written agreement, and appropriate surveillance in the framework of Reg EU 2024/1860</a></div><ul class="ecl-content-block__secondary-meta-container"><li class="ecl-content-block__secondary-meta-item"><svg class="ecl-icon ecl-icon--s ecl-content-block__secondary-meta-icon" focusable="false" aria-hidden="true" ><use 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