- What is the MDR, how it affects your clinical trials (00:06:29)
- New Application Procedures for Study Approval (00:09:20)
- Monitoring according to MDR and ISO 14155:2020 (00:09:52)
- GDPR Requirements (00:14:25)
- MDR new requirements for safety reporting during clinical investigations (00:12:21)
MEDICAL DEVICE REGULATION FOR CLINICAL TRIALS
The medical device regulation and the conduct of clinical trials are essential elements for market access in Europe. This is why a full-service organization like Meditrial can properly support the sponsors and clinical professionals to understand and comply with the new regulation.
With the new Medical Device Regulation now in force as of 26 May 2021, Meditrial has organized a dedicated training reserved to our customers and partners, to help you manage the transition for ongoing and new clinical trials.
WHY WE MUST UPDATE OUR TRIALS
The MDR is now implemented in every member state in Europe.
If you are just in the process of submitting a new trial, but it has not started yet, the Authorities will expect that you submit it in compliance with the MDR.
If you sponsor a trial that is already ongoing, you must update your safety procedures in accordance with the MDR by the deadline of May 26, 2021.
What does it mean to you?
- Your ongoing studies will need an amendment to gain approval for the changes
- Your planning and timelines will be affected by the new application procedures
- Your safety management must consider new definitions, process and timelines
- You will need to upgrade the essential study documents (protocol, IB, informed consent) to comply with new requirements
Are you ready?
- As the implementation of the EU MDR has already proven to be a complex and challenging process, it is important to ensure you are going in the right direction.
- For example, there are increased requirements surrounding the study design justification, greater focus on risk management, and more emphasis on patient rights and privacy.
- With Eudamed not yet available, national variations and adjustments have been implemented by the Member States. Are you aware of these special rules that apply to your study?
Join the Meditrial training
- This training will allow you a quick and rapid upgrade of your trials to the MDR.
- By attending the live session, all of your questions will be answered by regulatory experts in simplified language
- You will have access to dedicated tutorials and educational materials
- You will earn certification by passing your final test
Meditrial will not only ensure your medical device complies at every stage of its life cycle but that you ultimately achieve market approval.
- Final Test