{"id":27149,"date":"2023-02-16T09:00:45","date_gmt":"2023-02-16T08:00:45","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27149"},"modified":"2023-02-10T08:48:37","modified_gmt":"2023-02-10T07:48:37","slug":"europe-cybersecurity-directive-eu-2022-2555","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/02\/16\/europe-cybersecurity-directive-eu-2022-2555\/","title":{"rendered":"EUROPE: Cybersecurity Directive (EU) 2022\/2555"},"content":{"rendered":"<h2>The topic of cybersecurity is increasingly important nowadays, especially in critical areas such as public health and the medical sector: for this reason, the European Union intends to <strong>strengthen<\/strong> IT systems to <strong>ensure<\/strong> that everyone can benefit from services and use digital tools in an <strong>increasingly secure and reliable<\/strong> manner.<\/h2>\n<p>Since 2020, the European Commission and the European External Action Service (EEAS) have been working on an <a href=\"https:\/\/digital-strategy.ec.europa.eu\/en\/policies\/cybersecurity-strategy\">EU cybersecurity strategy<\/a> to strengthen <strong>Europe&#8217;s resilience against cyber threats<\/strong>, which was adopted <a href=\"https:\/\/www.consilium.europa.eu\/en\/press\/press-releases\/2021\/03\/22\/cybersecurity-council-adopts-conclusions-on-the-eu-s-cybersecurity-strategy\/\">in March 2021<\/a>.<\/p>\n<p>On 27 December 2022, <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022L2555&amp;from=EN\">Directive (EU) 2022\/2555 of the European Parliament and of the Council<\/a> on measures for a high common level of cybersecurity in the Union was published, which, after transposition by the Member States, will amend Regulation (EU) No. 910\/2014 and Directive (EU) 2018\/1972 <strong>as of 18 October 2024 <\/strong>and repeal Directive (EU) 2016\/1148 (NIS 2 Directive).<\/p>\n<p>Article 1 of Directive (EU) 2022\/2555 <strong>establishes<\/strong> obligations for Member States to adopt <strong>national<\/strong> cyber security <strong>strategies<\/strong> and to designate or create National Competent Authorities, cyber crisis management authorities, single security contact points (single points of contact) and cyber security incident response teams.<\/p>\n<p>The measure also defines cybersecurity <strong>risk management<\/strong> measures and reporting obligations for entities operating in highly critical sectors, including the medical sector, or otherwise critical, as well as cybersecurity <strong>information<\/strong> sharing and communication (<strong>vigilance<\/strong>) obligations.<\/p>\n<p>The Directive also has a strong impact in the <strong>health and medical sector<\/strong>, as a high criticality sector according to Annex I Dir.2022\/2555, and applies to several stakeholders including:<\/p>\n<ul>\n<li>EU designated reference laboratories to support national laboratories (Article 15 Reg. (EU) 2022\/2371.<\/li>\n<li>Manufacturers of medical devices considered critical during a public health emergency. The list of critical devices for public health emergencies is established in Article 22 of Regulation (EU) 2022\/123.<\/li>\n<li>Manufacturers of medical devices (Article 2, point 1 MDR (EU) 2017\/745) and in vitro diagnostic medical devices (Article 2, point 2 IVDR (EU) 2017\/746) with the exception of manufacturers medical devices considered critical during a public health emergency.<\/li>\n<\/ul>\n<p>The level of application of cybersecurity in the medical sector has already had an initial development with the MDR (EU) 2017\/745 and IVDR (EU) 2017\/746, which, in Annex I, define the need to <strong>handle personal data<\/strong> appropriately. Certainly, the publication of Directive 2022\/2555 brings an important benchmark for demonstrating compliance with the regulatory requirements imposed for data security.<\/p>\n<p>To stay informed about updates on requirements and regulatory changes in Europe and worldwide, <a href=\"https:\/\/md-24.us20.list-manage.com\/subscribe?u=672feff85a65d12563810beed&amp;id=3c9da60174\"><strong>subscribe to our Newsletter<\/strong><\/a>.<\/p>\n<h4><strong>&gt;&gt;&gt;<\/strong> Through our <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory consulting<\/a> services, <a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">CE certification support<\/a> and, where necessary, <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/european-authorised-representative-service\/\">European Authorised Representative<\/a>, Thema can support you in fulfilling the requirements of the MDR (EU) 2017\/745 Medical Device Regulations, including cybersecurity.<\/h4>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\">Contact us<\/a> for more information.<\/p>\n<p>Sources: <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32022L2555&amp;qid=1675353764565\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32022L2555&amp;qid=1675353764565<\/a><\/p>\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022L2555&amp;from=EN\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022L2555&amp;from=EN<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The topic of cybersecurity is increasingly important nowadays, especially in critical areas such as public health and the medical sector: for  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":27177,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-27149","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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