{"id":5062,"date":"2017-03-01T21:35:46","date_gmt":"2017-03-01T21:35:46","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=5062"},"modified":"2022-06-12T18:23:35","modified_gmt":"2022-06-12T18:23:35","slug":"eu-mdr-ivdr-final-versions-are-you-ready-transition-period-starts-soon","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2017\/03\/01\/eu-mdr-ivdr-final-versions-are-you-ready-transition-period-starts-soon\/","title":{"rendered":"EU MDR & IVDR – Final Versions – Are You Ready, Transition Period Starts Soon"},"content":{"rendered":"

\"\"<\/a>Final texts of the EU MDR<\/a> & IVDR<\/a> (R = Regulation) have been released recently\u00a0and start their transition periods sometime in the early to mid 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR has a 5 year transition period. \u00a0You should be starting your quality\u00a0planning now if you haven’t already and start talking with your Notified Body to make sure they will still be notified for your specific type of device\/technology as many Notified Bodies have lost their notifications<\/a>\u00a0and more are sure to fall or fail.The reason for this change from the MD & IVD Directives is because of the PIP Breast implant scandal and issues with implantable metal hips.<\/p>\n

Some of the changes manufacturers will have to deal with include:<\/p>\n

*Quality Management Systems
\n*Clinical\u00a0Evidence Requirements
\n*Authorized Representatives Requirements\u00a0and Liability
\n*You may need to change Notified Bodies if their scope changes\u00a0during the designation process
\n*Need to prepare and implement for Unique Device Identifiers (UDI), starting with the highest risk class
\n*Person responsible\u00a0for regulatory compliance in your\u00a0company – minimum requirements
\n*Classification rules will change & some devices that are not considered medical device currently will fall under the MDR
\n*Classification rules will impact IVDs significantly\u00a0under the IVDR
\n*Updates to post market surveillance & vigilance requirements
\n*Economic operators in the supply chain will have some changes to the obligations per the MDR or IVDR<\/p>\n

Here are some\u00a0resources to share with you:<\/p>\n

greenlight.guru Webinars on How to Prepare for the New EU Medical Device Regulations (MDR)<\/a>\u00a0and How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)<\/a><\/p>\n

For the following 3 BSI White Papers* please select the title from the BSI White Paper webpage<\/a>.<\/p>\n

BSI’s white paper* on the MDR “Planning for implementation of the European Union Medical Devices Regulations \u2013 Are you prepared?”<\/p>\n

BSI’s white paper* on the IVDR titled “How to prepare for and implement the upcoming IVDR \u2013 Dos and don\u2019ts”<\/p>\n

BSI’s white paper* on the MDR & IVDR draft text (article updated Oct 2015) titled “UPDATED: The proposed EU regulations for medical and in vitro diagnostic devices”<\/p>\n

BSI webpage for white papers<\/a>* has additional white papers on medical devices \/\u00a0IVDs and quality system requirements.<\/p>\n

One of my favorite blogs to follow on the MDR changes is Erik Vollebregt’s Medicaldeviceslegal.com<\/a> blog. \u00a0Erik does an excellent job providing really great information on the subject and keeping his finger on the pulse of the issue at hand.<\/p>\n

* Note, through out the BSI White paper series I have had the honor of being on the Advisory Panel to help shape the series and review each of the white papers to provide my years of experience in the medical device industry and the regulatory world.<\/p>\n

<\/a>De-notification of EU Notified Bodies under MDD<\/p>\n

The number of EU Notified Bodies (NBs) under the MDD has dropped from about 80\u00a0to less than 60 because of the increasingly more stringent NB requirements. \u00a0Are you sure your Notified Body scope still covers your products or are they de-notified? \u00a0The French Competent Authority (National Agency for Safety of Medicines and Health Product [ANSM]) in late 2016\u00a0published an Information Bulletin<\/a>.<\/p>\n

Also, what is going to happen when the Notified Bodies apply for designation under the MDR and when will your Notified Body get approved for the designation under the MDR. \u00a0The designation process may take a year or more and some NB’s may not get designated for all they expect or they may decide to shutter their doors, among other scenarios. \u00a0So, make sure to read the notifications in the above paragraph and also stay in close contact with your NB to make sure you don’t get left in the cold without a proper NB for your product lines.<\/p>\n

If you need help with your EU MDR or IVDR transition planning\u00a0please\u00a0email Leo Eisner at\u00a0Leo at EisnerSafety dot com<\/a>, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Final texts of the EU MDR & IVDR (R = Regulation) have been released recently\u00a0and start their transition periods sometime in the early to mid 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR<\/p>\n","protected":false},"author":4,"featured_media":6508,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[1314,1315,1316,1294,1317,1318,579,20,265,1173,12,1174,330],"class_list":["post-5062","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-bsi-white-papers","tag-eu-ivdr","tag-eu-ivdr-transition-planning","tag-eu-mdr","tag-eu-mdr-transition-plannning","tag-eu-notified","tag-eu-notified-bodies","tag-ivd","tag-ivdd","tag-ivdr","tag-mdd","tag-mdr","tag-medical-device"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5062","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=5062"}],"version-history":[{"count":6,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5062\/revisions"}],"predecessor-version":[{"id":6668,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5062\/revisions\/6668"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6508"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=5062"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=5062"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=5062"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}