2 Scope This guidance document is intended to provide clarification on the changes to a device that should be considered a “significant change in design or a significant change in the intended purpose” under MDR Article 120(3). Assessments should be made on a case-by-case basis. 1 The ...
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en 这个网站都是MDCG的指南 ...
MDCG 2020 - 3 Guidance on significant changes & annexes 关于根据MDD或AIMDD对证书所涵盖的设备进行的MDR第120条下的过渡条款重大变更的指南 2020年3月 本指导文件旨在澄清根据MDR第120(3)条应被视为“设计上的重大更改或预期用途的重大更改”的设备更改。 评估应根据具体情况进行。
In conclusion, the MDR represents a significant shift in the regulation of medical devices in the EU, with a focus on increasing transparency, accountability, and patient safety. By harmonizing the regulatory framework and imposing stricter requirements on manufacturers, the MDR aims to ensure that ...
Guidance for each of the required sections of the SSCP document SSCP文件中每个部分的指南1. The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, t…
is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. ...
Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices14. The concept act by converting energy includes conversion of energy in the device and/or conversion at the ...
This is because a change in pack quantity would lead to a misidentification of the device in this case and may 1 Regulation (EU) 2017/745 on medical devices. 2 Regulation (EU) 2017/746 on in vitro diagnostic medical devices. 3 See the 'UDI FAQ'. 4 Please see the MDCG guidance ...
2 Scope This guidance document is intended to provide clarification on the changes to a device that should be considered a “significant change in design or a significant change in the intended purpose” under MDR Article 120(3). Assessments should be made on a case-by-case basis. 1 The ...
significantimpactonthebenefit-riskanalysisandwhichhaveledormayleadtorisksto thehealthorsafetyofpatients,usersorotherpersonsthatareunacceptablewhen weighedagainsttheintendedbenefits.Trendsshouldbeidentifiedbythemanufacturer astheycanbeindicativeofachangeintherisk-benefitratio. Forfurtherinformationandclarificationonwhatcons...