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id="ecl-inpage-navigation-317381402-list"></ul></div></nav> </div> <div class="oe-theme-content-region ecl-col-l-9"> <div id="block-ewcms-theme-main-page-content" data-inpage-navigation-source-area="h2, div.ecl-featured-item__heading" class="ecl-u-mb-l"> <article dir="ltr"> <div> <div class="ecl"><div class="ecl-table-responsive"><table class="ecl-table"><thead class="ecl-table__head"><tr class="ecl-table__row"><th colspan="2" class="ecl-table__header"><h2>Jaki jest obszar Twojej działalności?</h2></th></tr></thead><tbody class="ecl-table__body"><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Jaki jest obszar Twojej działalności?"><a href="https://health.ec.europa.eu/document/download/3518b8dc-238a-4844-9f80-27aced75173a_en?filename=md_generic_fs_en.pdf">Nowe przepisy zapewniające bezpieczeństwo wyrobów medycznych</a></td><td class="ecl-table__cell"><a href="https://health.ec.europa.eu/document/download/d7eeed24-f158-4044-8f2c-1c6fee9f67ef_pl?filename=md_infographic-new-reg_pl.pdf">Infografiki: nowe rozporządzenie w sprawie wyrobów medycznych (MDR) i nowe rozporządzenie w sprawie wyrobów medycznych do diagnostyki in vitro (IVDR)</a> <br>(dostępne we wszystkich językach UE oraz w języku <a href="https://health.ec.europa.eu/document/download/d7eeed24-f158-4044-8f2c-1c6fee9f67ef_pl?filename=md_infographic-new-reg_pl.pdf">arabskim</a>, <a href="https://health.ec.europa.eu/document/download/7da3603e-01de-4f8f-bfe8-d87faa6a1437_en?filename=md_infographic-new-reg_zh.pdf">chińskim</a>, <a href="https://health.ec.europa.eu/document/download/06b6f706-ebcb-430e-beee-64b320000b82_en?filename=md_infographic-new-reg_ja.pdf">japońskim</a>, <a href="https://health.ec.europa.eu/document/download/f6b86b29-7e42-4873-80a3-de93626c646f_en?filename=md_infographic-new-reg_ru.pdf">rosyjskim</a>)</td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Jaki jest obszar Twojej działalności?"><p><a href="https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_pl?filename=timeline_mdr_pl.pdf">MDR – okresy przejściowe</a></p><p>IVDR – okresy przejściowe (infografika będzie dostępna wkrótce)</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_pl_0.pdf">Właściwe organy w krajach spoza UE/EOG</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Jaki jest obszar Twojej działalności?"><a href="https://health.ec.europa.eu/document/download/6c636d24-e6cd-49c9-ac8e-6e215a9cce25_pl?filename=procurementecosystem_factsheet_pl.pdf">Zamówienia wyrobów niemających przewidzianego zastosowania medycznego (MD) i wyrobów medycznych do diagnostyki in vitro (IVD)</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_pl">Pracownicy służby zdrowia i instytucje zdrowia publicznego</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Jaki jest obszar Twojej działalności?"><a href="https://health.ec.europa.eu/document/download/88eff4e3-9763-435e-a3b9-75aadfc8df65_pl?filename=md_manufacturers_factsheet_pl.pdf">Producenci wyrobów medycznych</a><br> <a href="https://health.ec.europa.eu/document/download/d7dded29-984b-4df7-bf6f-11d9af19097f_pl?filename=md_manufacturers_factsheet_annex_pl.pdf">Przewodnik krok po kroku</a></td><td class="ecl-table__cell"><a href="https://health.ec.europa.eu/document/download/82c113e2-7876-4405-9f5f-b2799c2f6a25_pl?filename=ivd_manufacturers_factsheet_pl.pdf">Producenci wyrobów medycznych do diagnostyki in vitro</a><br> <a href="https://health.ec.europa.eu/document/download/3f4f0cfd-fbcd-47e8-9282-193805b5f035_pl?filename=ivd_manufacturers_factsheet_annex_pl.pdf">Przewodnik krok po kroku</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Jaki jest obszar Twojej działalności?"><a href="https://health.ec.europa.eu/document/download/37879254-c7d6-487b-8fd9-06496e771465_pl?filename=importersdistributors_factsheet_pl.pdf">Upoważnieni przedstawiciele, importerzy i dystrybutorzy</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_pl">Producenci wyrobów niemających przewidzianego zastosowania medycznego</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Jaki jest obszar Twojej działalności?"><a href="https://health.ec.europa.eu/document/download/b865d8e9-081a-4601-a91a-f120321c0491_en?filename=md_mdcg_2021_mdsw_en.pdf">Czy twoje oprogramowanie jest wyrobem medycznym?</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">Niepowtarzalny kod identyfikacyjny wyrobu – UDI</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Jaki jest obszar Twojej działalności?"><a href="https://health.ec.europa.eu/document/download/e724bca0-7035-426e-9672-bd2404ebb6a7_pl?filename=md_q-a_emdn_pl.pdf">Europejska nomenklatura wyrobów medycznych (EMDN) – pytania i odpowiedzi</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" 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