{"id":33312,"date":"2021-10-06T00:01:55","date_gmt":"2021-10-06T00:01:55","guid":{"rendered":"https:\/\/www.3dnatives.com\/en\/?p=33312"},"modified":"2021-10-06T07:11:09","modified_gmt":"2021-10-06T07:11:09","slug":"3d-printed-medical-device-regulation-061020216","status":"publish","type":"post","link":"https:\/\/www.3dnatives.com\/en\/3d-printed-medical-device-regulation-061020216\/","title":{"rendered":"Is the EU Lagging Behind in 3D-Printed Medical Device Regulation?"},"content":{"rendered":"

Quite often here, we discuss the advances 3D printing is making in the medical sector<\/a>. So, you may be surprised to learn that the European Union is lagging well behind other countries when it comes to regulation regarding 3D-printed devices made for medical use. At least, this is according to researchers at the German FH M\u00fcnster University of Applied Sciences, who proclaim that governing bodies in other countries have less ambiguity in regulatory language used to govern the use of 3D-printed medical devices. Ambiguity in regulatory language can result in a stunted market and increased cost for businesses.<\/p>\n

The EU\u2019s regulation of 3D-printed medical devices<\/a> is covered by the European Medical Device Regulation\u00a0(MDR), which regulates the nearly 500,000 types of medical devices available on the EU market. The scrutiny around the EU’s regulations for 3D-printed medical devices has risen to attention due to an exception made in the ordinance for \u201cmass-produced devices which need to be adapted to meet the specific requirements of any professional user.<\/em>\u201d Which effectively means, medical products produced using additive manufacturing processes will not be considered custom-made.<\/p>\n

\"European

3D-printed medical device regulation is too ambiguous, according to German FH M\u00fcnster University of Applied Sciences. (Photo Credit: Carl Campbell on Unsplash)<\/p><\/div>\n

Regulation for 3D Printing Medical Devices<\/h3>\n

The largest claim being made by the FH M\u00fcnster researchers is that a “medical device Q&A’\u00a0 endorsed by the European Commission failed to clarify 3D printing\u2019s role in the medical sector, and rather, made things more confusing. In the study that examines the regulatory language, the researchers uncovered conflicting statements specifically related to existing MDG regulations and the newly released Q & A “clarification” which now distinguishes between \u2018patient-matched medical devices\u2019 and \u2018adaptable medical devices.\u2019<\/p>

\"\"<\/a><\/div>\n

Instead of \u201cremoving ambiguity as hoped,\u201d the scientists say that the document \u201cincreases uncertainty,\u201d and puts the EU medical industry in a position well behind the regulatory clarity governing medical device 3D printing in Australia and the United States. \u00a0The study highlights that many companies have yet to start implementing the new regulatory requirements\u2014particularly small businesses. Many companies are facing the obstacle of technical documentation, clinical evaluation, as well as post-market monitoring. As a consequence, 3D printing companies can face increased operational costs due to MDR, downsizing in their product portfolio, and fewer market launch of new products\u2014basically a bottleneck to innovation. You can learn more about the FH M\u00fcnster team’s regulatory research HERE<\/a><\/strong>.<\/p>\n

\"Shapeshift

EU regulation now distinguishes between \u2018patient-matched medical devices\u2019 and \u2018adaptable medical devices.\u2019 (Photo Credit: ShapeShift 3D)<\/p><\/div>\n

What do you think of the EU’s regulatory language regarding 3D printed medical devices? Let us know in a comment below or on our Facebook<\/a>\u00a0and\u00a0Twitter<\/a>\u00a0pages. Don\u2019t forget to sign up for our free weekly\u00a0newsletter<\/a>, with all the latest news in 3D printing delivered straight to your inbox!<\/p>\n

Cover Photo Credit: National Cancer Institute<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Quite often here, we discuss the advances 3D printing is making in the medical sector. So, you may be surprised to learn that the European Union is lagging well behind other countries when it comes to regulation regarding 3D-printed devices…<\/p>\n","protected":false},"author":6083,"featured_media":33368,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[32,1],"tags":[],"class_list":["post-33312","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/posts\/33312","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/users\/6083"}],"replies":[{"embeddable":true,"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/comments?post=33312"}],"version-history":[{"count":3,"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/posts\/33312\/revisions"}],"predecessor-version":[{"id":33392,"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/posts\/33312\/revisions\/33392"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/media\/33368"}],"wp:attachment":[{"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/media?parent=33312"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/categories?post=33312"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.3dnatives.com\/en\/wp-json\/wp\/v2\/tags?post=33312"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}