Spain: AEMPS gives MedTech companies another 11 months to adapt to Brexit
The Spanish Agency of Medicines and Medical Devices (AEMPS) moved to May 25th, 2021 the deadline for changing the labelling and instructions for use of medical devices due to Brexit.
This decision aims at allowing manufacturers to face the challenges imposed by the COVID-19 emergency.
For more details, please see:
- the original communication from AEMPS in Spanish language
- the communication translation (Meditrial´s translation).
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.
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A Practical RBQM Framework for Medical Device Trials
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EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
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What Swissmedic Fast-Track Means for Clinical Trial Sponsors
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FDA Breakthrough Device Acceleration
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The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
