The MDR and IVDR are in full flux still and there is a lot happening in the field of horizontal legislation, like Turkxit apparently having been averted in the last days before DOA, Swixit still under hectic negotiation, the Market Surveillance Regulation becoming applicable as of 16 July, t...
知情同意书ICF (Informed consentform)描述,包含ICF表和病人信息表 (patient information sheet),剩余样本(Left-over sample)不适用 V 安全纪录和报告的程序,包含可报告事件的定义。 W 早期结束临床试验的标准 X 随访的标准, 剩余样本(Left-over sample)不适用 Y 出版报告结果的政策和法律的需求 Z 列出仪器的技术...
Medical Devices Regulation (MDR) > In Vitro Diagnostic Regulation (IVDR) > Why choose BSI for your CE marking? BSI The Netherlands (2797) is a full-scope Notified Body designated for all three types of devices under MDR and IVDR:
Medical Device White Paper Series Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15 An overview of the requirements and practical considerations Authors - Anne Jury, Maddalena Pinsi Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15 Disclaimer – ...
An update to the 2020 Manufacturer’s Incident Report (MIR) form,new version 7.2.1together with aQuestions and Answersdocument on implementation. Publication of a new MDCG guidance documentMDCG 2020-1on Clinical Evaluation / Performance Evaluation of Medical Device (including IVD) Software. ...
The documentation is device specific, e.g., in the form of a checklist on a standard form Full size image Annex I, Chapter I: general requirements Chapter I focuses on device-specific risk management for the manufacture and use of IH-IVDs. IH-IVDs must be fit for purpose and safe; ...
知情同意书ICF (Informed consentform)描述,包含ICF表和病人信息表 (patient information sheet),剩余样本(Left-over sample)不适用 V 安全纪录和报告的程序,包含可报告事件的定义。 W 早期结束临床试验的标准 X 随访的标准, 剩余样本(Left-over sample)不适用 ...