{"id":9743,"date":"2019-06-12T09:41:32","date_gmt":"2019-06-12T07:41:32","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9743"},"modified":"2019-06-12T09:41:32","modified_gmt":"2019-06-12T07:41:32","slug":"what-is-the-period-of-grace-and-how-can-i-take-advantage-of-it","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/what-is-the-period-of-grace-and-how-can-i-take-advantage-of-it\/","title":{"rendered":"What is the “period of grace” and how can I take advantage of it?"},"content":{"rendered":"\n

The “period of grace<\/em>” is the time interval, which coincides with the due date, during which a CE certificate issued pursuant to Directive (MDD) 93\/42\/EEC can remain effective even after 26 May 2021, but not later than 26 May 2024.<\/p>\n\n\n\n

One of the conditions for a “period of grace<\/em>”\nCE certificate to remain valid until its natural due date is the demonstration\nof compliance, starting May 26, 2020, with the requirements of the MDR on post-market\nsurveillance, market surveillance, vigilance<\/strong> and obligations of registration<\/strong>\nof the Manufacturer and economic operators.<\/p>\n\n\n\n

It is important to point out that the MDR certificate is a new certification<\/strong>, not an amendment of the MDD. For this reason, the “period of grace<\/em>” does not also apply to class I devices or those that pass from self-certification to the control of a Notified Body (including the new IR<\/sub> class that will include reusable surgical instruments). The demonstration of compliance with the MDR for these devices must be total and complete<\/strong> starting May 26, 2021<\/strong>.<\/p>\n\n\n\n

Questions? Request more info from our specialists 
CONTACT US<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The “period of grace” is the time interval, which coincides with the due date, during which a CE certificate issued pursuant […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[892,1554],"tags":[],"class_list":["post-9743","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-mdr-impact-ce-mdd-certificates-period-of-grace"],"acf":[],"yoast_head":"\nWhat is the "period of grace" and how can I take advantage of it? - Thema Med<\/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.thema-med.com\/en\/2019\/06\/12\/what-is-the-period-of-grace-and-how-can-i-take-advantage-of-it\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What is the "period of grace" and how can I take advantage of it? 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