{"id":7217,"date":"2017-09-19T13:27:13","date_gmt":"2017-09-19T10:27:13","guid":{"rendered":"http:\/\/wwwen.anm.ro\/?page_id=7217"},"modified":"2026-05-21T15:03:57","modified_gmt":"2026-05-21T12:03:57","slug":"directive-si-regulamente","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/legislatie\/directive-si-regulamente\/","title":{"rendered":"Directives and regulations – Medical Devices"},"content":{"rendered":"

> Laws, ordinances and government decisions<\/a>
\n> Orders of the minister of health<\/a>
\n> Directives and regulations<\/a>
\n> Scientific council decisions<\/a><\/p>\n

DIRECTIVES AND REGULATIONS<\/b><\/span><\/p>\n

2025<\/strong><\/p>\n\n\n\n
\nCOMMISSION IMPLEMENTING REGULATION (EU) 2025\/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021\/2226 as regards the medical devices for which the instructions for use may be provided in electronic form
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2024<\/strong><\/p>\n\n\n\n
\nREGULATION (EU) 2024\/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices
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2023<\/strong><\/p>\n\n\n\n\n\n\n\n\n
\nCOMMISSION IMPLEMENTING REGULATION (EU) 2023\/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
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\nCOMMISSION DELEGATED REGULATION (EU) 2023\/2197 of 10 July 2023 amending Regulation (EU) 2017\/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
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\nCOMMISSION IMPLEMENTING REGULATION (EU) 2023\/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022\/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017\/745 of the European Parliament and of the Council
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\nREGULATION (EU) 2023\/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
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\nCOMMISSION DELEGATED REGULATION (EU) 2023\/502 of 1 December 2022 amending Regulation (EU) 2017\/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies
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\nCOMMISSION DELEGATED REGULATION (EU) 2023\/503 of 1 December 2022 amending Regulation (EU) 2017\/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies
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2022<\/strong><\/p>\n\n\n\n\n\n\n\n
\nCOMMISSION IMPLEMENTING REGULATION (EU) 2022\/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices
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\nCOMMISSION IMPLEMENTING REGULATION (EU) 2022\/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017\/745 as regards reclassification of groups of certain active products without an intended medical purpose (Annex XVI)
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\nCOMMISSION IMPLEMENTING REGULATION (EU) 2022\/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017\/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices
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\nCOMMISSION IMPLEMENTING REGULATION (EU) 2022\/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017\/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices
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\nREGULATION (EU) 2022\/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017\/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
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2020<\/strong><\/p>\n\n\n\n
\nREGULATION (EU) 2020\/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2020 amending Regulation (EU) 2017\/745 on medical devices, as regards the dates of application of certain of its provisions
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2019<\/strong><\/p>\n\n\n\n\n\n\n
\nAmendment to REGULATION (EU) 2017\/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No. 882\/2004 178\/2002 and Regulation (EC) No. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC – 03.05.2019
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\nAmendment to REGULATION (EU) 2017\/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No. 882\/2004 178\/2002 and Regulation (EC) No. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC – 27.12.2019
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\nAmendment to REGULATION (EU) 2017\/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU \u2013 03.05.2019
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\nAmendment to REGULATION (EU) 2017\/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU \u2013 27.12.2019
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2017<\/strong><\/p>\n\n\n\n\n
\nREGULATION (EU) 2017\/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No. 882\/2004 178\/2002 and Regulation (EC) No. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC
\nConsolidated version which includes 2019 amendments
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\nREGULATION (EU) 2017\/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU
\nConsolidated version which includes 2019 amendments
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2008<\/strong><\/p>\n\n\n\n
\nRegulation (EC) No 765\/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339\/93
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2002<\/strong><\/p>\n\n\n\n\n
\nNSR-04 \u2013 Rules for radioprotection in medical exposure, approved by Joint MSF\/CNCAN Order no. 285\/79\/2002
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\nNSR-04 \u2013 Annex 5: Acceptability criteria for radiologic equipment
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> Laws, ordinances and government decisions > Orders of the minister of health > Directives and regulations > Scientific council […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4802,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-7217","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/7217","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=7217"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/7217\/revisions"}],"predecessor-version":[{"id":9493,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/7217\/revisions\/9493"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/4802"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=7217"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}