The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices according to transparency obligations under the regulation.
Moreover, the Commission’s Medical Devices Coordination Group (MDCG) released a template for clinical evaluation assessment reports (CEAR) for notified bodies to document their assessments of clinical evidence for medical devices undergoing conformity assessments.
Meditrial can help, Contact us now
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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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.
