The European Commission’s Medical Device Coordination Group (MDCG) released guidance about the process for transitioning CE certificates for devices carrying ancillary substance which could be considered a medicinal product and those incorporating animal tissues to the MDR.
Ancillary substances
Medical devices that incorporate an ancillary substance that could be considered a medicinal product, must undergo a consultation with a medicinal product authority or the European Medicines Agency (EMA).
Following changes are introduced:
- a 210-day timeframe for the competent authority or EMA to provide an opinion for initial consultations and,
- a 60-day window for supplementary consultations
- notified bodies may not issue a certificate if the opinion is unfavorable.
Animal tissue
For devices manufactured using animal tissues, the first certification under the MDR requires the submission of a complete summary evaluation report to the competent authorities.
For more details, please see the guidance document from MDCG.
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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