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Pripreme za nove propise - Europska komisija

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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>Koje je vaše područje djelatnosti?</h2></th></tr></thead><tbody class="ecl-table__body"><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Koje je vaše područje djelatnosti?"><a href="https://health.ec.europa.eu/document/download/3518b8dc-238a-4844-9f80-27aced75173a_en?filename=md_generic_fs_en.pdf">Novi propisi za osiguravanje sigurnosti medicinskih proizvoda.</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">Infografike; „Nove uredbe” (Uredba o in vitro dijagnostičkim medicinskim proizvodima i Uredba o medicinskim proizvodima)</a> (dostupne na svim jezicima EU-a te na <a href="https://health.ec.europa.eu/document/download/d7eeed24-f158-4044-8f2c-1c6fee9f67ef_en?filename=md_infographic-new-reg_en.pdf">arapskom</a>, <a href="https://health.ec.europa.eu/document/download/7da3603e-01de-4f8f-bfe8-d87faa6a1437_en?filename=md_infographic-new-reg_zh.pdf">kineskom</a>, <a href="https://health.ec.europa.eu/document/download/06b6f706-ebcb-430e-beee-64b320000b82_en?filename=md_infographic-new-reg_ja.pdf">japanskom</a> i<a href="https://health.ec.europa.eu/document/download/f6b86b29-7e42-4873-80a3-de93626c646f_en?filename=md_infographic-new-reg_ru.pdf">&nbsp;ruskom</a>)</td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Koje je vaše područje djelatnosti?"><p><a href="https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf">Prijelazna razdoblja u okviru Uredbe o medicinskim proizvodima</a></p><p>Prijelazna razdoblja u okviru Uredbe o in vitro dijagnostičkim medicinskim proizvodima (vizualni materijal bit će objavljen uskoro)</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">Nadležna tijela u zemljama izvan EU-a/EGP-a</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Koje je vaše područje djelatnosti?"><a href="https://health.ec.europa.eu/document/download/6c636d24-e6cd-49c9-ac8e-6e215a9cce25_en?filename=procurementecosystem_factsheet_en.pdf">Nabava medicinskih proizvoda i in vitro dijagnostičkih medicinskih proizvoda</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?prefLang=hr">Zdravstveni djelatnici i zdravstvene ustanove</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Koje je vaše područje djelatnosti?"><a href="https://health.ec.europa.eu/document/download/88eff4e3-9763-435e-a3b9-75aadfc8df65_en?filename=md_manufacturers_factsheet_en.pdf">Proizvođači medicinskih proizvoda</a><br> + <a href="https://health.ec.europa.eu/document/download/d7dded29-984b-4df7-bf6f-11d9af19097f_en?filename=md_manufacturers_factsheet_annex_en.pdf">detaljni vodič</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">Proizvođači in vitro dijagnostičkih medicinskih proizvoda</a><br> + <a href="https://health.ec.europa.eu/document/download/3f4f0cfd-fbcd-47e8-9282-193805b5f035_en?filename=ivd_manufacturers_factsheet_annex_en.pdf">detaljni vodič</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Koje je vaše područje djelatnosti?"><a href="https://health.ec.europa.eu/document/download/37879254-c7d6-487b-8fd9-06496e771465_en?filename=importersdistributors_factsheet_en.pdf">Ovlašteni predstavnici, uvoznici i distributeri</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">Proizvođači proizvoda bez medicinske namjene</a></td></tr><tr class="ecl-table__row"><td class="ecl-table__cell" data-ecl-table-header="Koje je vaše područje djelatnosti?"><a href="https://health.ec.europa.eu/document/download/b865d8e9-081a-4601-a91a-f120321c0491_en?filename=md_mdcg_2021_mdsw_en.pdf">Je li vaša programska oprema medicinski proizvod?</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">Jedinstvena identifikacija proizvoda – UDI</a></td></tr><tr class="ecl-table__row"><td 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