May 15, 2023Miguel Angel Gómez

New update of MDCG 2020-3 significant changes for devices under MDD

/*! elementor - v3.12.1 - 02-04-2023 */ .elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=“.svg”]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block} 📢 An 𝘂𝗽𝗱𝗮𝘁𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟯 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 on 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗶𝗻 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝘁𝗵𝗲 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗽𝗿𝗼𝘃𝗶𝘀𝗶𝗼𝗻 𝗼𝗳 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟭𝟮𝟬 𝗼𝗳 𝘁𝗵𝗲 𝗠𝗗𝗥 has been published for medical devices certified under the MDD or AIMDD..

📄 This guidance establishes the reference framework for determining any change that 𝘭𝘦𝘨𝘢𝘤𝘺 devices may undergo, taking into account Regulation (EU) 2023/607, which establishes that devices that continue to comply with the AIMDD/MDD may be placed on the market or put into service until 31 December 2027 or 31 December 2028, as applicable, provided that the conditions laid down in Article 120(3c) are met.

✔️ class I devices (MDD), for which an EC declaration of conformity was drawn up before 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;✔️ devices covered by a valid EC certificate issued under the AIMDD or the MDD before 26 May 2021.🖋️🖋️The conditions laid down in Article 120(3c) of the MDR include, among others, that legacy devices must continue to comply with the AIMDD/MDD, as applicable, and that there are no significant changes in the design or intended purpose of the device.

You can obtain this guidance here 👉

https://health.ec.europa.eu/system/files/2023-05/mdcg_2020-3_en.pdf