{"id":4397,"date":"2021-08-19T03:29:00","date_gmt":"2021-08-19T03:29:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4397"},"modified":"2025-12-03T05:38:15","modified_gmt":"2025-12-03T05:38:15","slug":"medical-devices-regulatory-updates-august-volume-2","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/medical-devices-regulatory-updates-august-volume-2\/","title":{"rendered":"Medical Devices \u2013 Regulatory Updates \u2013 August Volume 2"},"content":{"rendered":"\n<span class=\"wp-elements-a03d606f374bdb584f5abea6928c909f\"  id=\"europe\"><\/span><br><br>\n<h2 class=\"wp-block-heading\" style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">EUROPE<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>1. Guidance on MHRA\u2019s Return to On\u2011Site Inspections\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">With the easing of COVID\u201119 restrictions, the MHRA inspectorate will begin resuming on\u2011site, risk\u2011based GxP inspections in the UK starting in September, moving toward a full inspection schedule by October 2020. A blended model of remote and on\u2011site inspections will be applied.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>2. MDCG Guidance on Using MDSAP Audit Reports\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">This guidance explains how notified bodies should consider MDSAP Medical Device Regulatory Audit Reports when conducting surveillance audits under the MDR (Regulation (EU) 2017\/745) and IVDR (Regulation (EU) 2017\/746).&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Annexes included in the document highlight:\u00a0<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>where MDR\/IVDR\u2011relevant information appears in MDSAP audit reports, and\u00a0<\/li>\n\n\n\n<li>examples demonstrating how clinical evaluation, supplier control, and post\u2011market surveillance requirements align with corresponding MDSAP sections.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>3. MHRA Guidance for Manufacturers on Vigilance\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers must report adverse medical device incidents to the competent authority of the country where the event occurred.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>New EU MDR and IVDR provisions strengthen vigilance and post\u2011market surveillance requirements, including:\u00a0<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>shorter reporting timelines,\u00a0<\/li>\n\n\n\n<li>introduction of periodic summary update reports (PSURs), and\u00a0<\/li>\n\n\n\n<li>broadened definitions of medical devices.\u00a0<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Updated FSN and MIR forms now align with current and upcoming regulations.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>4. JAZMP Safety Notices for Medical Devices \u2013 June 2020\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers or their representatives must notify JAZMP and device users in writing about safety corrective actions.&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-c5e100f7c77f4f930f3f2c9a420aa58e wp-block-paragraph\">Reports must comply with Article 15 of the Rules on the Vigilance of Medical Devices (Official Gazette of the RS, 61\/10).&nbsp;<\/p>\n\n\n\n<p style=\"color:#000\">The monthly list of security notices may not be complete. The list includes safety notifications received by JAZMP. If you receive a safety notification from the manufacturer that is not on the monthly list, please let us know by e-mail:&nbsp;<a style=\"color:#00bab9\" href=\"mailto:meddev.vigilance@jazmp.si\">meddev.vigilance@jazmp.si.<\/a><\/p>\n\n\n\n<span class=\"wp-elements-ee64318d976b4389443aba50cef4f654\"  id=\"us\"><\/span><br><br>\n<h2 class=\"wp-block-heading\" style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">US FDA<\/h2>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-a755dd168077b04ba92bcfb2179bb85c\"><strong>5. FDA Decisions on Accessory Classification Requests\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">FDA may approve or decline an Accessory Classification Request. When approved, classification orders are published for public access. Detailed information on submission processes and review timelines is available under FDA\u2019s Medical Device Accessories resources.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>6. Reclassification Proposal: Non\u2011Invasive Bone Growth Stimulators\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">FDA is proposing to reclassify non\u2011invasive bone growth stimulators (product codes LOF and LPQ) from Class III to Class II with special controls.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This change would shift the regulatory pathway from PMA to the 510(k) process, thereby reducing associated regulatory burdens while maintaining safety and effectiveness requirements.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>7. New Guidance: Cutaneous Electrodes \u2013 Safety and Performance Criteria\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">This guidance supports the Safety and Performance Based Pathway by providing predefined performance criteria for cutaneous electrodes used for recording purposes.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers may rely on these criteria instead of conducting direct performance comparisons with predicate devices.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>8. New Guidance: Conventional Foley Catheters \u2013 Safety and Performance Criteria\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Under the same pathway, FDA has issued performance criteria for conventional Foley catheters.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Submitters can use these criteria to demonstrate substantial equivalence without direct predicate comparison testing.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>9. De Novo Classification Summaries\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The De Novo pathway, established under FDAMA (1997) and updated under FDASIA (2012), allows classification of novel medical devices initially placed in Class III after an NSE determination.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sponsors may now submit a De Novo request directly without first filing a 510(k).<\/p>\n\n\n\n<span  id=\"india\"><\/span><br><br>\n<h2 style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">INDIA &#8211; DGFT<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>10. Lifting of Export Restrictions on Ventilators\u00a0<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">DGFT has removed all COVID\u201119\u2013related restrictions on the export of ventilators, reflecting improved domestic availability and reduced risk of shortages.&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-d002407e1a8990cb940873ba8380ec19 wp-block-paragraph\">Unlike other pandemic\u2011related products, where limited export allowances were introduced before full relaxation (e.g., certain PPE categories), ventilator export rules were lifted entirely without interim steps.<\/p>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-927c70617f5f183ae903ddc7892f010b wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\"><strong>Tags:<\/strong> <\/mark><\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/eu-medical-device-labelling\/\" rel=\"tag\">EU Medical Device Labelling<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/europe-medical-devices-regulatory-updates\/\" rel=\"tag\">Europe medical devices regulatory updates<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/india-dgft-regulatory-updates\/\" rel=\"tag\">India dgft regulatory updates<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-device-labelling-requirements\/\" rel=\"tag\">Medical device labelling requirements<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-devices-regulatory-updates\/\" rel=\"tag\">Medical Devices Regulatory Updates<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/regulatory-updates-august-volume-2\/\" rel=\"tag\">Regulatory Updates August Volume 2<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/us-medical-devices-regulatory-updates\/\" rel=\"tag\">us medical devices regulatory updates<\/a><\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EUROPE 1. Guidance on MHRA\u2019s Return to On\u2011Site Inspections\u00a0 With the easing of COVID\u201119 restrictions, the MHRA inspectorate will begin resuming on\u2011site, risk\u2011based GxP inspections in the UK starting in September, moving toward a full inspection schedule by October 2020. A blended model of remote and on\u2011site inspections will be applied. 2. MDCG Guidance on [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1877,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[645],"tags":[494,492,493,489,463,490,491],"class_list":["post-4397","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","tag-eu-medical-device-labelling","tag-europe-medical-devices-regulatory-updates","tag-india-dgft-regulatory-updates","tag-medical-device-labelling-requirements","tag-medical-devices-regulatory-updates","tag-regulatory-updates-august-volume-2","tag-us-medical-devices-regulatory-updates"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Medical Devices \u2013 Regulatory Updates \u2013 August Volume 2<\/title>\r\n<meta name=\"description\" content=\"Medical device manufacturers are required to carry out regular regulatory updates. 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