MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation
New guideline for Europe on trial changes has been published!
MDCG 2021-28 – Substantial modification of clinical investigation under Medical Device Regulation.
The sponsor of a clinical investigation is required to submit an application to the Member State in which a clinical investigation is to be conducted and to notify its intention to introduce substantial modification, via the EUDAMED database. Until EUDAMED is fully functional, the MDCG 2021-28 provides a template for notifying Competent Authorities of any substantial modification to a clinical investigation.
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Table of Contents
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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
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FDA Breakthrough Device Acceleration
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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.
