The MHRA issued a guidance on the 3D printing of medical devices or component parts during COVID-19.
The requirements manufacturers need to meet when 3D printing will depend on whether the item is a medical device, or a piece of personal protective equipment (PPE). This is determined by the manufacturer and primarily depends on the intended purpose for the individual product being manufactured. In general, products intended to protect the wearer will be PPE whilst those intended to protect a patient are likely to be medical devices.
The guidance includes details on:
For more details, please see the guidance from MHRA.
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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