In cases where a manufacturer intends to claim equivalence to a device not manufactured by him, the MDR requires that the two manufacturers have a contract in place that explicitly allows the manufacturer of the
1a.Contract with the manufacturer of the Equivalent Device allowing full access to the technical documentation on an ongoing basis与“等同器械”制造商签订合同,允许其持续获得全部技术文件• Level of access: Full.• 获取水平:满足。• N/A 1b.Device Under Evaluation is a design modification of ...
Such technical documentation has to be kept and made availabletonationalcompetent authoritiesupontheirrequest. 制造商还必须准备和维护产品的相关技术文件,以支持 EC 或欧盟符合性声明 中声称的合规性。 此类技术文件必须应国家主管当局的要求提供并保存。 12 13 For certain medical devices and personal protective...
AnnexXVoftheMDR.TheInvestigator’sBrochure(IB)ispartoftherequireddocumentationand isoneofthemeansbywhichthesponsoristofulfiltherequirementinsection2.7ofChapterIof AnnexXVoftheMDRwhichstatesthattheinvestigatorshallhaveaccesstotechnicalandclinical dataregardingthedevicethatisbeinginvestigated.Thisincludestheintendedpurpose...
3 No full revision of the technical documentation in accordance with Annexes II and III MDR required. Page 6 of 11 Medical Devices Medical Device Coordination Group Document MDCG 2021-25 Such an approach respects the wording of Article 120(3) MDR. At the same time it extends the application...
documentationofsupportingdataforanIVDmaybeconductedpriortotheplacing onthemarketorputtingintoservice.Astheperformanceevaluationwillbeupdated throughoutthelifecycleofanIVD,thisdocumentalsoaddressesprinciplesrelatedto post-marketsurveillance,suchaspost-marketperformancefollow-up. ...
In this case the manufacturer will compile the Technical Documentation and submit it to the Notified Body. The Notified body then performs an assessment regarding the usefulness of the substance as part of the medical device, taking account of the intended purpose of the device. ...
This article demonstrates how MDCG 2024-3 links the legal text of the EU MDR with the ISO standard while guiding manufacturers on how to ensure alignment with the technical documentation and, particularly, the planned clinical evaluation of the subject device. It also highlights...
MDCG 2020-7_guidance_pmcf_plan_template_en
Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 May 2020 This document has been endorsed ...