detailedrequirementsoncontentoftheimplantcard,andtoMDCGguidancedocumentsMDCG 2019-819andMDCG2021-1120foradditionalguidance. 2.3.Pre-clinicalevaluation Accordingtosection2.3,chapterII,AnnexXVoftheMDR,theIBshouldincludeapre-clinical evaluationbasedonrelevantpre-clinicaltestingandexperimentaldata,inparticularin-design...
1.Guidance on specific aspects of clinical evaluation for legacy devices对遗留器械临床评价的具体方面的指导 Sections 6.1 – 6.5 below provide guidance on each stage of the clinical evaluation process ofMDRAnnex XIV Part A Section 1. 下文第6.1-6.5节对MDR附件XIV第A部分第1节的临床评价过程的每个阶段...
MDR将其定义为一组具有相同或相似的预期目的或技术共性的器械,允许以不反映特定特征的通用方式对它们进行分类。 2.Reference documents参考文件 This document provides facilitative guidance to the requirements of MDR Chapter VI and Annex XIV, and references the following MDD/AIMDD guidance documents: 本文件为M...
内容提示: 2022/5/21 Guidance - MDCG endorsed documents and other guidancehttps://ec.europa.eu/health/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en 1/15Public HealthGuidance - MDCG endorsed documents and otherguidanceThis page provides a range of ...
economicoperators,andintendstoprovideguidanceonrelevantrequirementsunderthe Regulations.WhereclarificationisalreadycoveredbyotherMDCGguidances,thisguidance onauthorisedrepresentativesincludesareference. Therequirementtohaveanauthorisedrepresentativeisnotapplicabletodevicesintended ...
Unless major objections are raised by the MDCG, the task-force suggests: forwarding this report to the relevant MDCG workings groups as orientation to be taken into account for the development of guidance documents and publishing this report on the Commission’s website in order to ...
MDCG Provides Roadmap for MDR Device Transition An updated guidance from the Medical Device Coordination Group (MDCG) explains the modifications that can be made to devices certified under the legacy regulatory system without rendering the device ineligible for the EU market. ...
近日,欧盟发布了2024年第一份指南文件“Device Specific Vigilance Guidance (DSVG) Template”,旨在帮助制造商协调警戒报告,并为特定器械提供指导。 本次提供的特定器械指南模板如下: Cardiac ablation心脏消融手术器械 Coronary stents冠脉支架 Cardiac implantable electronic devices (CIEDs)心脏植入式电子器械 ...
In addition to the classification rules set out in Annex VIII of MDR, the manufacturers must also take account of any applicable legal acts and consider guidance documents which may support the classification of their device. Practical example A simple wound drainage system has usually three ...
2.7/1 rev. 4 are not fully aligned with the MDR and that further guidance to address the differences would be of benefit to industry and other stakeholders. Only the text of the MDR is legally binding. In cases of divergence between the MEDDEV 2.7/1 rev. 4, this ...