MDCG issues guidance on safety reporting for device studies under MDR
The European Commission’s Medical Device Coordination Group (MDCG) issued a guidance explaining how safety reporting in clinical investigations of medical devices should be performed under the MDR.
The guidance applies to:
- premarket clinical investigations of non-CE marked devices,
- premarket clinical investigations of CE marked devices used outside their intended uses
- device studies covered under MDR Article 82
- certain postmarket clinical follow-up investigations, such as those involving procedures outside the normal conditions of use of the device and those imposing additional invasive or burdensome procedures
- trials initiated under the Active Implantable Medical Devices Directive and the Medical Devices Directive
- medical devices used in clinical trials for medicinal products, unless the study is not meant to assess the safety or performance of a CE-marked device and the device is used according to its intended purpose.
For more details, please see the guidance from MDCG.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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Table of Contents
Build a Defensible Clinical Evidence Strategy Under EU MDR
Build a defensible clinical evidence strategy under MDR Annex XIV, from the clinical evaluation plan to PMCF and notified body review.
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.
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.
