MDCG 2022-2 Guidance on general principles of clinical evidence for in Vitro Diagnostic medical devices (IVDs)
New #MDCG Guidance on general principles for #clinicalevidence and the continuous process of performance evaluation for #IVDs has been published
The guidance describes the approach by which collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing on the market or putting into service.
As the #performanceevaluation will be updated throughout the life cycle of an #IVD, this document also addresses principles related to post-market surveillance.
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Table of Contents
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
