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.
Free Helpline +1-800-901-4286
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This article provides general information and does not constitute regulatory, legal, clinical, or compliance advice. Requirements and appropriate processes may vary by study, product, jurisdiction, and organization. Medigen Suite functionality should be used in accordance with applicable regulations, study documentation, and internal procedures.
