{"id":12359,"date":"2022-03-03T16:48:46","date_gmt":"2022-03-03T15:48:46","guid":{"rendered":"https:\/\/www.laffineur.com\/?p=12359"},"modified":"2022-03-03T16:48:46","modified_gmt":"2022-03-03T15:48:46","slug":"medical-safety-regulation","status":"publish","type":"post","link":"https:\/\/www.laffineur.com\/en\/medical-safety-regulation\/","title":{"rendered":"Medical Safety Regulation"},"content":{"rendered":"<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/AUTO\/?uri=CELEX:32021R2282&amp;qid=1645545142208&amp;rid=3\">Regulation (EU) 2021\/2282 of the European Parliament and of the Council of 15\u00a0December 2021 on health technology assessment and amending Directive 2011\/24\/EU (Text with EEA relevance)<\/a><\/p>\n<p>This Regulation aims to achieve a high level of protection of health for patients and users while ensuring the smooth functioning of the internal market as regards medicinal products, medical devices and\u00a0<em>in vitro<\/em>\u00a0diagnostic medical devices. At the same time, this Regulation establishes a framework to support Member State cooperation and the measures needed for clinical assessment of health technologies. Both objectives are being pursued simultaneously. As regards Article\u00a0114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation sets out the procedures and the rules for carrying out joint work and establishing a framework at Union level.<\/p>\n<p>This Regulation establishes:<\/p>\n<ul>\n<li>A support framework and procedures for cooperation of Member States on health technologies at Union level;<\/li>\n<li>A mechanism which lays down that any information, data, analyses and other evidence required for the joint clinical assessment of health technologies is to be submitted by the health technology developer only once at Union level;<\/li>\n<li>Common rules and methodologies for the join clinical assessment of health technologies<\/li>\n<\/ul>\n<p>However, this Regulation does not affect Member States\u2019 competence to draw conclusions on the relative effectiveness of health technologies or to take decisions on the use of a health technology in their specific national health context. It does not interfere with the exclusive national competence of Member States, including those for national pricing and reimbursement decisions, or affect any other competences which concern Member States\u2019 management and delivery of health services or medical care or the allocation of resources assigned to them.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulation (EU) 2021\/2282 of the European Parliament and of the Council of 15\u00a0December 2021 on health technology assessment and amending Directive 2011\/24\/EU (Text with EEA relevance) This Regulation aims to achieve a high level of protection of health for patients and users while ensuring the smooth functioning of the internal market as regards medicinal products, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[151],"tags":[],"class_list":["post-12359","post","type-post","status-publish","format-standard","hentry","category-european-law"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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