{"id":10896,"date":"2022-10-05T14:59:00","date_gmt":"2022-10-05T14:59:00","guid":{"rendered":"https:\/\/dev.platform24.com\/?post_type=blog24&#038;p=10896"},"modified":"2023-12-10T16:17:36","modified_gmt":"2023-12-10T16:17:36","slug":"mdr-nya-regelverket-okar-tryggheten-nar-varden-digitaliseras","status":"publish","type":"blog24","link":"https:\/\/dev.platform24.com\/sv\/blog\/blog24\/mdr-nya-regelverket-okar-tryggheten-nar-varden-digitaliseras\/","title":{"rendered":"MDR: Nya regelverket \u00f6kar tryggheten n\u00e4r v\u00e5rden digitaliseras"},"content":{"rendered":"\n<p><strong>Vad inneb\u00e4r det nya regelverket i praktiken?<\/strong><\/p>\n\n\n\n<p>MDR \u00f6kar patients\u00e4kerheten och skapar tydlighet kring vad som f\u00f6rv\u00e4ntas av tillverkaren och produkten samt av hur ansvarsf\u00f6rdelningen ser ut vid anv\u00e4ndning. MDR inneb\u00e4r en avsev\u00e4rd sk\u00e4rpning av kraven p\u00e5 teknisk dokumentation, nytta-risk-utv\u00e4rdering, klinisk utv\u00e4rdering, samt \u00f6vervakning av eftermarknaden.&nbsp;<\/p>\n\n\n\n<p><strong>Det svenska h\u00e4lsoteknikbolaget Platform24 \u00e4r<\/strong> ett av de f\u00f6rsta svenska h\u00e4lsoteknikbolag som erh\u00e5ller MDR-certifiering<strong>. Bolagets produkt Triage24, en <\/strong>digital automatiserad l\u00f6sning f\u00f6r v\u00e5rdguidning och triagering,<strong> <\/strong>\u00e4r ocks\u00e5 den f\u00f6rsta triagel\u00f6sningen p\u00e5 den europeiska marknaden som certifierats. CE-m\u00e4rkningen inneb\u00e4r att produkten lever upp till de nya h\u00f6gre kraven f\u00f6r medicinsk utrustning och f\u00e5r marknadsf\u00f6ras i EU. Certifieringen betyder ocks\u00e5 att bolaget kan expandera och utveckla den tekniska plattformen vilket inkluderar f\u00f6r\u00e4ndringar av l\u00f6sningarna och nya funktioner.&nbsp;<\/p>\n\n\n\n<p class=\"has-text-align-center\"><a href=\"https:\/\/platform24.com\/se\/event\/webinarium-hur-paverkar-mdr-vardens-digitalisering\/\">Se v\u00e5rt inspelade webinar &#8221;Hur p\u00e5verkar MDR v\u00e5rdens digitalisering?&#8221; h\u00e4r!<\/a><\/p>\n\n\n\n<p>Skiftet fr\u00e5n MDD till MDR inneb\u00e4r betydligt str\u00e4ngare krav p\u00e5 produkten inklusive sp\u00e5rbarhet, klinisk utv\u00e4rdering och \u00f6vervakning av eftermarknaden men ocks\u00e5 p\u00e5 cybers\u00e4kerheten, anv\u00e4ndbarhet och expertis hos ansvariga personer. <strong>Tobias Perdahl medicinsk chef p\u00e5 Platform24, vad har det h\u00e4r inneburit f\u00f6r er som bolag?<\/strong><\/p>\n\n\n\n<ul class=\"is-style-p24-list wp-block-list\">\n<li>Ja, det ska inte stickas under stol med att MDR-certifieringen har varit en l\u00e5ng och kr\u00e4vande process. Men att leva upp till dessa v\u00e4ldigt strikta standarder \u00e4r ocks\u00e5 helt i linje med Platform24:s mission att vara en verklig nyckelspelare i den transformationen av v\u00e5rden som nu p\u00e5g\u00e5r. De h\u00f6gre f\u00f6rv\u00e4ntningarna p\u00e5 anv\u00e4ndbarhet och kliniska bevis \u00e4r viktiga f\u00f6r b\u00e5de oss som bolag och f\u00f6r v\u00e5rden om vi ska n\u00e5 m\u00e5let om en tillg\u00e4nglig, effektiv och j\u00e4mlik v\u00e5rd \u00f6ver hela linjen.&nbsp;&nbsp;<\/li>\n<\/ul>\n\n\n\n<p><strong>Vilken f\u00f6r\u00e4ndring kan det nya regelverket inneb\u00e4ra f\u00f6r era kunder, t.ex. regionerna?<\/strong><\/p>\n\n\n\n<ul class=\"is-style-p24-list wp-block-list\">\n<li>Eftersom vi sett att m\u00e5nga andra f\u00f6retag har haft problem att klara av certifieringen, b\u00e5de uppfylla kraven och hitta en Notified Body, kan det p\u00e5 kort sikt faktiskt bli ett bekymmer eftersom det inneb\u00e4r att produkter helt enkelt f\u00f6rsvinner fr\u00e5n marknaden. Samtidigt \u00e4r det ju f\u00f6rst\u00e5s en enorm f\u00f6rdel i att man som kund och v\u00e5rdgivare nu har ett bevis p\u00e5 att den funktionalitet som tillverkaren h\u00e4vdar ocks\u00e5 finns i verkligheten och \u00e4r kontrollerad. Det \u00f6kar tryggheten f\u00f6r b\u00e5de v\u00e5rdgivare och slutanv\u00e4ndare och det \u00f6kar f\u00f6rst\u00e5s trov\u00e4rdigheten kring den nytta och s\u00e4kerhet som digital medicinteknisk mjukvara inneb\u00e4r. Det blir ocks\u00e5 l\u00e4ttare f\u00f6r kunden att st\u00e4lla krav p\u00e5 uppdateringar i ett livscykelperspektiv. Med en MDR-certifierad produkt kan kunden k\u00e4nna sig trygg med att f\u00f6retaget har l\u00e5ngsiktiga f\u00f6ruts\u00e4ttningar att bedriva ansvarsfull produktutveckling inom medicinteknisk mjukvara.<\/li>\n<\/ul>\n\n\n\n<p><strong>Ser du andra intressanta konsekvenser av MDR-certifieringen?<\/strong><\/p>\n\n\n\n<p>\u2013&nbsp; Ja, jag tycker att ett sp\u00e4nnande perspektiv \u00e4r den h\u00f6ga niv\u00e5 av \u201danv\u00e4ndarv\u00e4nlighet\u201d som kr\u00e4vs f\u00f6r att minimera risker till f\u00f6ljd av avvikande patientbeteende. V\u00e5ra l\u00f6sningar ska fungera f\u00f6r varje l\u00e4kare och patient i ett sjukv\u00e5rdssystem. Genom att samla allt i en enda ing\u00e5ng skapas s\u00f6ml\u00f6sa fl\u00f6den f\u00f6r alla anv\u00e4ndare \u2013 personal, l\u00e4kare och patienter \u2013 inte bara de \u201ddigitalt kunniga\u201d som aktivt v\u00e4ljer digitala v\u00e5rdalternativ. Alla moduler \u00e4r tillg\u00e4ngliga genom plattformens digitala \u201cPatient Front Door\u201d, vilket effektiviserar anv\u00e4ndarupplevelsen och l\u00e5ter fokus ligga p\u00e5 patientv\u00e5rd snarare \u00e4n teknik, avslutar Tobias Perdahl.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vad inneb\u00e4r det nya regelverket i praktiken? MDR \u00f6kar patients\u00e4kerheten och skapar tydlighet kring vad&#8230;<\/p>\n","protected":false},"author":1,"featured_media":9996,"menu_order":0,"template":"","meta":{"_acf_changed":false,"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_EventAllDay":false,"_EventTimezone":"","_EventStartDate":"","_EventEndDate":"","_EventStartDateUTC":"","_EventEndDateUTC":"","_EventShowMap":false,"_EventShowMapLink":false,"_EventURL":"","_EventCost":"","_EventCostDescription":"","_EventCurrencySymbol":"","_EventCurrencyCode":"","_EventCurrencyPosition":"","_EventDateTimeSeparator":"","_EventTimeRangeSeparator":"","_EventOrganizerID":[],"_EventVenueID":[],"_OrganizerEmail":"","_OrganizerPhone":"","_OrganizerWebsite":"","_VenueAddress":"","_VenueCity":"","_VenueCountry":"","_VenueProvince":"","_VenueState":"","_VenueZip":"","_VenuePhone":"","_VenueURL":"","_VenueStateProvince":"","_VenueLat":"","_VenueLng":"","_VenueShowMap":false,"_VenueShowMapLink":false,"footnotes":""},"tags":[163],"blog-cat":[105],"class_list":["post-10896","blog24","type-blog24","status-publish","has-post-thumbnail","hentry","tag-digital-halsa","blog-cat-blog-sv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDR: Nya regelverket \u00f6kar tryggheten n\u00e4r v\u00e5rden digitaliseras - Platform24<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR: Nya regelverket \u00f6kar tryggheten n\u00e4r v\u00e5rden digitaliseras - Platform24\" \/>\n<meta property=\"og:description\" content=\"Vad inneb\u00e4r det nya regelverket i praktiken? 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