Publication by the UK MHRA of new rules forregulating medical devices from 1 January 2021in Great Britain and Northern Ireland. August 2020: Publication ofCommission Implementing Regulation (EU) 2020/1207, containing the common specifications for the reprocessing of single-use devices. ...
1. The Commission shall be assisted by a Committee on Medical Devices. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 1. 欧盟委员会应得到一个医疗器械委员会的协助。该委员会应是第182/2011号条例(EU)所指的委员会。 2. Where reference is made to this ...
The Commission also proposes improvements to the CE certification process for innovative devices. It commits to be working with the Medical Devices Coordination Group (MDCG) to address the structural problems of the MDR, with a priority to find solutions for “orphan” dev...
Stay on top of MDR developments by consulting the website of the European Commission (DG Grow, Unit D4) (since 1 January 2020,DG Sante, Unit B6) and European industry associations such asMedTech Europe,COCIRandEucope. For further background about the MDR, please s...
5. Where justified on account of the similarity between a device with an intended medical purpose placed on the market and a product without an intended medical purpose in respect of their characteristics and risks, the Commission is empowered to adopt delegated acts in accordance with Article 115...
BSI implementation of the Amending Regulation NB confirmation letters for MDR applications In late August, the EU Commission published aflowchartto identify whether or not a device is covered by the extended transitional period. The flowchart should help to dete...
category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation...
The Commission is currently, in collaboration with Member States, looking into the possibility of a gradual release of the remaining modules. 13. Why was the application of the Medical Devices Regulation postponed by a year? The decision to postpone the date of application of the Medical Devices...
https://health.ec.europa.eu/medical-devices-eudamed/overview_en EUDAMED模块公布的时间表 通用规范、指南的征求意见稿 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives_en 征求意见 European Commission资讯更新 https://ec.europa.eu/growth/news_en ...
3. Proposal for a regulation of the European Parliament and of the Council on Medical Devices. September 26, 2012. European Commission website. http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf. Accessed January 6, 2015. ...