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Bliv klar til de nye forordninger - Europa-Kommissionen
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class="ecl-table__header"><h2>Hvilke aktiviteter udfører du?</h2></th></tr></thead><tbody class="ecl-table__body"><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Hvilke aktiviteter udfører du?"><a href="https://health.ec.europa.eu/document/download/3518b8dc-238a-4844-9f80-27aced75173a_en?filename=md_generic_fs_en.pdf">Nye regler vedrørende medicinsk udstyrs sikkerhed</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">Infografik: "De nye forordninger" (forordningen om in vitro-diagnostik og forordningen om medicinsk udstyr)</a> <br>(udarbejdet på alle EU-sprog og <a href="https://health.ec.europa.eu/document/download/d7eeed24-f158-4044-8f2c-1c6fee9f67ef_en?filename=md_infographic-new-reg_en.pdf">arabisk</a>, <a href="https://health.ec.europa.eu/document/download/7da3603e-01de-4f8f-bfe8-d87faa6a1437_en?filename=md_infographic-new-reg_zh.pdf">kinesisk</a>, <a href="https://health.ec.europa.eu/document/download/06b6f706-ebcb-430e-beee-64b320000b82_en?filename=md_infographic-new-reg_ja.pdf">japansk</a> og <a href="https://health.ec.europa.eu/document/download/f6b86b29-7e42-4873-80a3-de93626c646f_en?filename=md_infographic-new-reg_ru.pdf">russisk</a>)</td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Hvilke aktiviteter udfører du?"><p><a href="https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf">Overgangsperioder (forordningen om medicinsk udstyr)</a></p><p>Overgangsperioder (forordningen om in vitro-diagnostik) (illustration kommer snart)</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">Kompetente myndigheder i lande uden for EU/EØS</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Hvilke aktiviteter udfører du?"><a href="https://health.ec.europa.eu/document/download/6c636d24-e6cd-49c9-ac8e-6e215a9cce25_en?filename=procurementecosystem_factsheet_en.pdf">Indkøb af medicinsk udstyr og medicinsk udstyr til in vitro-diagnostik</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">Sundhedsfagligt personale og sundhedsinstitutioner</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Hvilke aktiviteter udfører du?"><a href="https://health.ec.europa.eu/document/download/88eff4e3-9763-435e-a3b9-75aadfc8df65_en?filename=md_manufacturers_factsheet_en.pdf">Fabrikanter af medicinsk udstyr</a><br><a href="https://health.ec.europa.eu/document/download/d7dded29-984b-4df7-bf6f-11d9af19097f_en?filename=md_manufacturers_factsheet_annex_en.pdf">+ trin for trin-vejledning</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">Fabrikanter af udstyr til in vitro-diagnostik</a><br><a href="https://health.ec.europa.eu/document/download/3f4f0cfd-fbcd-47e8-9282-193805b5f035_en?filename=ivd_manufacturers_factsheet_annex_en.pdf">+ trin for trin-vejledning</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Hvilke aktiviteter udfører du?"><a href="https://health.ec.europa.eu/document/download/37879254-c7d6-487b-8fd9-06496e771465_en?filename=importersdistributors_factsheet_en.pdf">Autoriserede repræsentanter, importører og distributører</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">Producenter af udstyr, der ikke er bestemt til medicinske formål</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Hvilke aktiviteter udfører du?"><a href="https://health.ec.europa.eu/document/download/b865d8e9-081a-4601-a91a-f120321c0491_en?filename=md_mdcg_2021_mdsw_en.pdf">Er din software medicinsk udstyr?</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">Unik udstyrsidentifikationskode (UDI)</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Hvilke aktiviteter udfører du?"><a href="https://health.ec.europa.eu/document/download/e724bca0-7035-426e-9672-bd2404ebb6a7_en?filename=md_q-a_emdn_en.pdf">Europæisk nomenklatur for medicinsk udstyr (EMDN) – Spørgsmål og svar</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 class="ecl-row"><div class="ecl-content-item-block__item contextual-region ecl-u-mb-l ecl-col-12 ecl-col-l-6 "><article class="ecl-card" lang="en" ><div class="ecl-card__body"><div class="ecl-content-block ecl-card__content-block" 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