{"id":1100,"date":"2020-11-24T11:43:48","date_gmt":"2020-11-24T10:43:48","guid":{"rendered":"https:\/\/www.medical-magnesium.com\/?p=1100"},"modified":"2020-11-24T11:43:48","modified_gmt":"2020-11-24T10:43:48","slug":"mdr-moratorium-a-halftime-report","status":"publish","type":"post","link":"https:\/\/www.medical-magnesium.com\/en\/2020\/11\/24\/mdr-moratorium-a-halftime-report\/","title":{"rendered":"MDR moratorium: A halftime report"},"content":{"rendered":"

[vc_row][vc_column width=”1\/1″][vc_column_text]In 2017, the European Commission has agreed on and published a new regulatory framework for medical devices to substitute the present Medical Device Directive<\/span>, thereby increasing the scrutiny on medical device manufactures and\u00a0<\/span>supply consistent and practicable rules EU-wide<\/span>.<\/span>\u00a0<\/span><\/p>\n

In the beginning,\u00a0<\/span>the MDR was often understood as a major burden for both established and new medical device\u00a0<\/span>companies<\/span>\u00a0due the increased requirements for pre-clinical data and post-market surveillance.<\/span>\u00a0Originally, manufacturers of medical devices were given a\u00a0three\u00a0<\/span>year<\/span>\u00a0transition period until May 26<\/span>th<\/span>\u00a02020\u00a0to duly adapt their internal processes and products to the new regulation.<\/span>\u00a0<\/span><\/p>\n

During the transition period, however, it became clear that the MDR is not only a challenge for manufactures, but that notified bodies and competent authorities themselves encountered a variety of obstacles as well leading the entire transition onto a rather\u00a0<\/span>rocky<\/span>\u00a0road.\u00a0<\/span>In late 2019, only a small fraction of notified bodies\u00a0<\/span>was<\/span>\u00a0designated for MDR due to\u00a0<\/span>a significant<\/span>\u00a0<\/span>delay\u00a0<\/span>with<\/span>in the designation\u00a0<\/span>process.\u00a0<\/span>T<\/span>he MDCG\u00a0<\/span>(Medical Device Coordinating Group)\u00a0<\/span>was\u00a0<\/span>also\u00a0<\/span>way behind their schedule for\u00a0<\/span>relevant\u00a0<\/span>guidance documents<\/span>\u00a0intended to clarify and substantiate the European Commission\u2019s expectations on how to\u00a0<\/span>follow<\/span>\u00a0the new rules<\/span>,<\/span>\u00a0and the European database for medical devices (Eudamed) seems to be delayed by a matter of years<\/span>\u00a0even<\/span>.<\/span>\u00a0<\/span>And then: Covid-19.<\/span>\u00a0<\/span>[\/vc_column_text][vc_custom_heading]European Comission deciding for a 12 month extension[\/vc_custom_heading][vc_column_text]As a result, the European Commission decided to extend the transition period by one year. <\/span>This extension period has now reached half time, but\u00a0<\/span>still<\/span>:<\/span>\u00a0only 17 out of 48 notified bodies that have applied for designation until recently have\u00a0actually been\u00a0designated yet.<\/span>[1]<\/span>\u00a0<\/span>In addition, although quite\u00a0a number of\u00a0guidance documents has been published already, t<\/span>he list of\u00a0<\/span>guidance documents under development is constantly growing. While there were 30 MEDDEV guidelines available under the MDD, more than 40 MDCG\u00a0<\/span>guidances<\/span>\u00a0have been published up to now \u2013 some of them have already been revised – and another 36 documents are currently on the schedule.<\/span>[2]<\/span>\u00a0<\/span>In summary,<\/span>\u00a0it appears that a lot of open questions and uncertainties are still to be addressed even half a year after reaching the original MDR-deadline.<\/span>\u00a0<\/span><\/p>\n

Logically, t<\/span>he Medical Device Regul<\/span>a<\/span>tion (MDR)<\/span>\u00a0has been the main topic among medical device manufacturers\u00a0<\/span>from all divisions\u00a0<\/span>for the past years now and with its\u00a0<\/span>implementation still in progress<\/span>, the debate on how\u00a0<\/span>t<\/span>he elevated expectations for quantity and quality on clinical data\u00a0<\/span>will\u00a0a<\/span>ctually a<\/span>ffect\u00a0the industry<\/span>\u00a0still<\/span>\u00a0<\/span>lives<\/span>\u00a0on.<\/span>\u00a0<\/span>Of note, t<\/span>he transition from MDD\u00a0<\/span>to<\/span>\u00a0MDR comes with considerable costs for\u00a0<\/span>established\u00a0<\/span>manufacturers not only\u00a0in regard to\u00a0the time and personnel required for\u00a0<\/span>implementing the<\/span>\u00a0changes<\/span>,<\/span>\u00a0or the increased service fees from the notified bodies, but especially\u00a0in regard to\u00a0the revised general safety and performance requirements (formally: essential requirements).<\/span>\u00a0A recent survey from a German EDC s<\/span>e<\/span>rvice provider indicates that medical device companies spend approximately 5% of their annual revenue<\/span>\u00a0for MDR compliance alone.<\/span>[3]<\/span>\u00a0It has thus often been feared that a considerable number of products will drop out from the market \u2013 especially those for orphan diseases and rare conditions – for their manufacturers to cope with the rising costs and that innovation of new products decelerates due to this increased level of required clinical data<\/span>, making the life especially difficult<\/span>\u00a0for young business<\/span>es<\/span>\u00a0and start-up companies.\u00a0<\/span>\u00a0<\/span>[\/vc_column_text][vc_custom_heading]Our approach at medical magnesium[\/vc_custom_heading][vc_column_text]Being founded in\u00a0<\/span>2015,\u00a0<\/span>our team<\/span>\u00a0at<\/span>\u00a0medical magnesium\u00a0<\/span>was<\/span>\u00a0faced with the upcoming regulatory changes early on<\/span>.\u00a0<\/span>We\u00a0<\/span>implement<\/span>ed<\/span>\u00a0the future requirements into our\u00a0<\/span>current\u00a0<\/span>procedures<\/span>,\u00a0<\/span>anticipat<\/span>ed<\/span>\u00a0<\/span>the need for sufficient clinical data on our MDR projects<\/span>\u00a0early on and\u00a0<\/span>allocat<\/span>ed<\/span>\u00a0<\/span>our resources accordingly<\/span>.<\/span>\u00a0<\/span>This<\/span>\u00a0allo<\/span>wed us\u00a0<\/span>to dynamically\u00a0<\/span>render<\/span>\u00a0<\/span>our process to the respective needs and shift our\u00a0<\/span>focus even on short notice.\u00a0<\/span>H<\/span>alf-time through the transition,\u00a0<\/span>we\u00a0<\/span>thus\u00a0<\/span>managed<\/span>\u00a0<\/span>to achieve our first main goals as a medical device company on the fly by receiving the CE mark for our first devices<\/span>\u00a0under the MDD.\u00a0<\/span>Our believe in<\/span>\u00a0procedural dynamic<\/span>s<\/span>\u00a0and\u00a0<\/span>open discussion among all company departmen<\/span>t<\/span>s (from development to clinical affairs)<\/span>\u00a0allowed us to anticipate the MDR\u00a0<\/span>moratorium<\/span>\u00a0early on<\/span>\u00a0and<\/span>\u00a0<\/span>specifically guide our resources onto<\/span>\u00a0certain projects to speed up the process of product validation and certification. As a result, we ha<\/span>d<\/span>\u00a0been able to draft and submit the complete technical\u00a0<\/span>file<\/span>\u00a0for our\u00a0<\/span>latest<\/span>\u00a0<\/span>mm.<\/span>X<\/span>\u00a0implant, the\u00a0mm.CS,<\/span>\u00a0<\/span>early before deadline and<\/span>\u00a0have<\/span>\u00a0finally receive<\/span>d<\/span>\u00a0the CE mark for our\u00a0third class III\u00a0implant.<\/span>\u00a0<\/span><\/p>\n

Being able to achieve these goals\u00a0<\/span>during this rather turbulent time of MDR transition\u00a0<\/span>and the<\/span>\u00a0<\/span>ongoing health crisis<\/span>\u00a0<\/span>not only f<\/span>ills us with pride.\u00a0<\/span>It\u00a0<\/span>lets\u00a0<\/span>us believe<\/span>\u00a0that\u00a0<\/span>small business<\/span>\u00a0can certainly stand their ground<\/span>\u00a0in the MDR regulated<\/span>\u00a0medical device<\/span>\u00a0market<\/span>\u00a0<\/span>and allows us to face the future confidently<\/span>.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

Author: MG<\/strong><\/em>\u00a0<\/span><\/p>\n

[1]<\/span>https:\/\/ec.europa.eu\/health\/sites\/health\/files\/md_newregulations\/docs\/notifiedbodies_overview_en.pdf<\/span><\/a>\u00a0<\/span><\/p>\n

[2]<\/span>https:\/\/ec.europa.eu\/health\/sites\/health\/files\/md_sector\/docs\/mdcg_ongoing_guidancedocs_en.pdf<\/span><\/a>\u00a0<\/span><\/p>\n

[3]<\/span>https:\/\/climedo.de\/press\/climedo-health-veroeffentlicht-umfrage-zu-den-wahren-kosten-der-eu-mdr-in-unternehmen\/<\/span><\/a>\u00a0<\/span>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

[vc_row][vc_column width=”1\/1″][vc_column_text]In 2017, the European Commission has agreed on and published a new regulatory framework for medical devices to substitute […]<\/p>\n","protected":false},"author":1,"featured_media":1098,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-1100","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\nMDR moratorium: A halftime report - medical magnesium<\/title>\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.medical-magnesium.com\/en\/2020\/11\/24\/mdr-moratorium-a-halftime-report\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR moratorium: A halftime report - 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