In the past few months, 2 new regulations have been put into place in the world of clinical trials. The EU Clinical Trials Regulation and the Medical Devices Regulation (MDR) (EU 2017/745) have been implemented. This has created a new need for training teams to streamline trials, and be compliant.
Here are a few crucial things that you might need to consider when it comes to making sure your clinical trial is up to date and compliant, as well as inspection ready.
Are You EU CTR Ready?
The EU CTR intends to create harmony between member states and ensure easier cooperation between them, as well as with sponsors. This will also bring improved safety standards, more transparency with the public, and make submission and assessment processes easier.
This will be through the Clinical Trial Information System (CTIS), and this brings a single entry portal to all clinical trials across Europe. It’s all about compliance, and brings clarity to member states about the submission process, and who is responsible for each action. There are stricter timelines, and requests for information (RFI) processes have changed.
Factors you’ll need to consider:
- Are all documents updated and compliant?
- Are your deferral strategies and request procedures implemented?
- Is everything ready for public presentation because of the new transparency requirements?
- Are your staff up to date and compliant with their new roles?
EU CTR brings a new set of regulations to the forefront, so make sure you’re ready with our new checklist here.
Get Up To Date With MDR
The transition from MDD to MDR is a big one, and the impact on medical device research within Europe is significant. From May 26th, all clinical trials on medical devices must follow the MDR.
This new legislation has a more holistic view of the process, from trial to approval. There are significant changes also to evaluations for implants and class III devices, with a strong need for PMCF and CER for all devices.
There are also altered timelines to consider.
EUDAMED becomes the central database for medical devices, providing an overview of the lifecycle of devices in the EU, and integrating different systems to collate and process information.
The most important thing is not to risk non-compliance and delays and ensure that your team is up to date with the MDR.
How Can GCP Central Help?
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