{"id":19828,"date":"2021-12-17T10:03:03","date_gmt":"2021-12-17T09:03:03","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=19828"},"modified":"2021-12-17T10:03:03","modified_gmt":"2021-12-17T09:03:03","slug":"medical-devices-significant-change-article-120-mdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/12\/17\/medical-devices-significant-change-article-120-mdr\/","title":{"rendered":"When are changes to a device considered a significant change under Article 120 MDR?"},"content":{"rendered":"\n

If you are a Manufacturer\nof Medical Devices<\/strong> with a valid certificate issued by a Notified Body under\nDirective 90\/385\/EEC (AIMDD<\/strong>) or Directive 93\/42\/EEC (MDD<\/strong>), you can\nplace your devices on the market even after May 26, 2021 (date of full\napplication of MDR (EU) 2017\/745) and no later than May 27, 2024. <\/p>\n\n\n\n

However, as defined by Art.\n120<\/strong> c. 3 MDR, “A device with a certificate that was issued in\naccordance with Directive 90\/385\/EEC or Directive 93\/42\/EEC may be placed on\nthe market, provided that there are no significant changes in the design and\nintended purpose”<\/strong>. <\/p>\n\n\n\n

What should you do in case of changes to your Medical Device?<\/strong><\/h2>\n\n\n\n

You will have to\nunderstand if this is a significant change in the design and purpose of the\nMedical Device to be communicated to the Notified Body (ref. NBOG Doc -PBG 2014\n– 03).<\/p>\n\n\n\n

If the change is not\nsignificant<\/strong>, the CE MDD \/ AIMDD Certificate remains valid.<\/p>\n\n\n\n

If the change is\nsignificant<\/strong> to be communicated to the Notified Body<\/strong> (NB)<\/strong> and determines\nthe end of the CE Certificate validity, then the CE MDD\/AIMDD Certificate loses\nits validity. If, on the other hand, the change is significant to be\ncommunicated to the NB but the NB approves the change, the CE Certificate remains\nvalid. <\/p>\n\n\n\n

Even if the change is not significant under Art.120 MDR, it might be\nsignificant for the NBOG PBG 2014 \u2013 03 \u201cGuidance for manufacturers and\nNotified Bodies on reporting of Design Changes and Changes of the Quality\nSystem”, so the change may still need to be reported to the NB.<\/p>\n\n\n\n

How to understand if changes to Medical Devices are significant or not?<\/strong><\/h2>\n\n\n\n

To help you understand\nwhether a change can be considered significant or not in the design or intended\nuse of the device under Article 120, c. 3 MDR, we refer to the MDCG 2020-3<\/strong>\n“Guidance on significant changes regarding the transitional provision\nunder Article 120 of the MDR with regard to devices covered by certificates\naccording to MDD or AIMDD”.<\/p>\n\n\n\n

You can find below 6 Interactive\nFlow Charts<\/strong>, divided into 1 main chart<\/strong> and 5 sub-charts<\/strong>: <\/p>\n\n\n\n