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

helpline@meditrial.net