{"id":10588,"date":"2018-12-14T14:23:42","date_gmt":"2018-12-14T13:23:42","guid":{"rendered":"https:\/\/php8.plastv.de\/?p=10588"},"modified":"2018-12-14T14:23:42","modified_gmt":"2018-12-14T13:23:42","slug":"medpharmplast-europe-conference-gave-insights-in-brexit-mdr-ivdr-and-vdi","status":"publish","type":"post","link":"https:\/\/plas.tv\/?p=10588","title":{"rendered":"MedPharmPlast Europe conference gave insights in Brexit, MDR, IVDR and VDI"},"content":{"rendered":"<h3><strong>Over 35 participants made the MPPE Conference on 5 December a big success.<\/strong><\/h3>\n<p>To kick-off the day,<em> James Stern, President of MedPharmPlast Europe (MPPE) <\/em>gave an update about the associations activities in 2018 and an outlook for 2019. MedPharmPlast Europe counts 20 members from all over Europe, Sanofi was the last member to join in 2018, Elix Polymers will become member as of 2019. &#8220;Next year, our Regulatory Taskforce will be more active than ever. Our priorities are to engage with the <strong>MDR <\/strong>authorities via the <strong>Medical Device Coordination Group<\/strong> and billateral meetings with the European Commission. Other major issues\u00a0to work on will be <strong>European (and US)\u00a0Pharmacopoeia<\/strong> and possible<strong> regulation on nanomaterials<\/strong>.&#8221;, said James Stern. In 2019, MPPE will moreover present an improved scanning tool for its members to assess regulations of substances, including MDR.<\/p>\n<p>In the second presentation of the day, MedPharmPlast Europe member <em>Anja Gottschalk, Application Development\u00a0Engineer Healthcare at\u00a0Borealis<\/em>, presented the view of material suppliers on the <strong>VDI 2017\u00a0Medical-Grade Plastics Guidelines.<\/strong> As Brexit is also a hot topic in the Medical Plastics Industry,\u00a0<em>Mark Lloyd Davies, J&amp;J<\/em>\u00a0then presented the status of the <strong>Brexit negotiations<\/strong> and the actions <em>Johnson &amp; Johnson<\/em> undertook to prepare for the different possible scenarios.<\/p>\n<p>As there are several uncertanties regarding the upcoming <strong>Medical Device Regulation<\/strong>, three presentations of the conference were dedicated to the topic. First, <em>Fran\u00e7oise Schlemmer, Director of\u00a0Team-NB<\/em> presented the notified body perspective of the implementation of the new regulations. Afterwards, <em>Salvatore Scalzo, DG Grow,<\/em> gave an in-depth update from the <strong>European Commission\u00a0on MDR, IVDR and the Future EU UDI System<\/strong>. Last but not least,\u00a0<em>Christian Pommereau, Principal Engineer at Sanofi<\/em>\u00a0provided the\u00a0view from the industry. He stressed the fact that the changes brought by the MDR are extremly difficult to manage, however, according to him an association like MedPharmPlast Europe can help to tackle the issues together as an industry.<\/p>\n<p>After his closing words, James Stern (Albis)\u00a0announced that Steve Duckworth (Clariant), former Vice-President of MPPE, whil replace him in the position of President. Michael Blaszkiewicz (Sabic), already Board member of MPPE\u00a0will take on the role of Vice-President until the end of 2019.<\/p>\n<p>In case you are interested in MPPE membership or our future events please contact us via info@medpharmplasteurope.org.<\/p>\n<p><strong>In 2019, MedPharmPlast Europe will organize its annual public summer conference in July. Date and place will be communicated in January.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>To kick-off the day, James Stern, President of MedPharmPlast Europe (MPPE) gave an update about the associations activities in 2018 and an outlook&#8230;<\/p>\n","protected":false},"author":2,"featured_media":10589,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24,16],"tags":[],"series":[],"class_list":["post-10588","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-plas-tv-meldungen-auf-der-startseite-unterhalb-slider","category-plast-tv-textmeldungen"],"_links":{"self":[{"href":"https:\/\/plas.tv\/index.php?rest_route=\/wp\/v2\/posts\/10588","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/plas.tv\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/plas.tv\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/plas.tv\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/plas.tv\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=10588"}],"version-history":[{"count":1,"href":"https:\/\/plas.tv\/index.php?rest_route=\/wp\/v2\/posts\/10588\/revisions"}],"predecessor-version":[{"id":10590,"href":"https:\/\/plas.tv\/index.php?rest_route=\/wp\/v2\/posts\/10588\/revisions\/10590"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/plas.tv\/index.php?rest_route=\/wp\/v2\/media\/10589"}],"wp:attachment":[{"href":"https:\/\/plas.tv\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=10588"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/plas.tv\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=10588"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/plas.tv\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=10588"},{"taxonomy":"series","embeddable":true,"href":"https:\/\/plas.tv\/index.php?rest_route=%2Fwp%2Fv2%2Fseries&post=10588"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}