{"id":382,"date":"2026-08-11T10:10:37","date_gmt":"2026-08-11T08:10:37","guid":{"rendered":"https:\/\/www.pqra.gr\/the-prrc-software-and-ai-compliance-roles-for-modern-devices\/"},"modified":"2026-08-27T11:36:56","modified_gmt":"2026-08-27T09:36:56","slug":"the-prrc-software-and-ai-compliance-roles-for-modern-devices","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/the-prrc-software-and-ai-compliance-roles-for-modern-devices\/","title":{"rendered":"The PRRC, Software and AI: Compliance Roles for Modern Devices"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Two of the hardest questions in medical device compliance today are who takes responsibility, and how the rules apply to software and artificial intelligence. The MDR answers the first; a fast-moving set of regulations answers the second.<\/strong><\/p>\n<h2>The Person Responsible for Regulatory Compliance<\/h2>\n<p>Under Article 15, every manufacturer must have at least one <strong>Person Responsible for Regulatory Compliance (PRRC)<\/strong> with appropriate expertise. The current qualification requirement is either a relevant degree plus at least one year of regulatory or quality experience with devices, or four years of such experience.<\/p>\n<p>The PRRC ensures conformity is properly checked before release, that technical documentation and the declaration of conformity stay current, and that post-market and vigilance obligations are met. <strong>Micro and small enterprises<\/strong> need not employ a PRRC on staff but must have one permanently at their disposal &mdash; and authorised representatives must always have one available.<\/p>\n<p>The Commission&#8217;s December 2025 proposal would simplify Article 15 &mdash; replacing the detailed qualification criteria with a general &#8220;requisite expertise&#8221; test and clarifying that the PRRC may act on a <strong>contractual basis<\/strong> rather than as an employee. As with the rest of that package, it is a proposal and not yet in force.<\/p>\n<h2>Software as a Medical Device<\/h2>\n<p>Software that meets the definition of a medical device is regulated like any other device, and is classified mainly under Rule 11 &mdash; which pushes most clinical decision-support software to Class IIa or higher. Guidance document MDCG 2019-11 sets out how the rule is interpreted.<\/p>\n<h2>Where AI meets the MDR<\/h2>\n<p>AI-based devices now sit at the intersection of two regimes. Under the <strong>EU AI Act<\/strong> (Regulation (EU) 2024\/1689), an AI system that is a medical device &mdash; or a safety component of one &mdash; and requires notified body assessment under the MDR is treated as a <strong>high-risk AI system<\/strong>. That layers obligations on risk management, data governance, transparency, human oversight and logging on top of the MDR. Guidance (MDCG 2025-6) has begun to clarify how the two frameworks align.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA provides PRRC support, software classification and the regulatory strategy for AI-enabled devices across the MDR and AI Act.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Talk to us about software and AI devices &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Two of the hardest questions in medical device compliance today are who takes responsibility, and how the rules apply to software and artificial intelligence. The MDR answers the first; a fast-moving set of regulations answers the second. The Person Responsible for Regulatory Compliance Under Article 15, every manufacturer must have at least one Person Responsible [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":397,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,14],"tags":[],"class_list":["post-382","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The PRRC, Software and AI: Compliance Roles for Modern Devices - PQRA<\/title>\n<meta name=\"description\" content=\"Two of the hardest questions in medical device compliance today are who takes responsibility, and how the rules apply to software and artificial\u2026\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pqra.gr\/el\/the-prrc-software-and-ai-compliance-roles-for-modern-devices\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The PRRC, Software and AI: Compliance Roles for Modern Devices - 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