See also Question 17 of the above 2 mentioned CAMD 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)....
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。
The MDCG provides guidance and support to member states and stakeholders in implementing the EU medical device regulations to ensure harmonization and consistency across the EU. The MDCG was established under the Medical Device Regulation (MDR) to assist the European Commission and member states in ...
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…
involvement when reviewing applicable requirements as part of their ‘appropriate surveillance’, as the notified bodies responsible for the appropriate surveillance in accordance 1 The terminology of ‘legacy devices’ and ‘old devices’ is in line with existing MDCG guidance such as MDCG-2021-13 ...
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 ...
See also Question 17 of the above 2 mentioned CAMD 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)....
significantimpactonthebenefit-riskanalysisandwhichhaveledormayleadtorisksto thehealthorsafetyofpatients,usersorotherpersonsthatareunacceptablewhen weighedagainsttheintendedbenefits.Trendsshouldbeidentifiedbythemanufacturer astheycanbeindicativeofachangeintherisk-benefitratio. Forfurtherinformationandclarificationonwhatcons...