The medical device regulation EU 2017/745 allows Member States some adjustments for local implementation.

If you sponsor a trial in Germany, you must learn what are the new ordinances and guidelines for the implementation of the MDR.
The Authorities will expect that you follow the new procedures by the deadline of May 26, 2021.

You will be expected to amend your study and train the Investigators to meet the new German requirements.

• Do I need to compile the new reporting form for all previous events?
No. BfArM has all records of prior events. Only submit events occurring after 26 May
• Should the quarterly Report only contain SAEs from Germany?
No. You should include all reportable SAEs in your study.

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, Germany has introduced specific rules with regards to investigator safety reporting.

Partnering with Meditrial will allow you a quick and rapid upgrade of your trials to the MDR.
• All of your questions will be answered by regulatory experts in simplified language
• You will have access to dedicated tutorials and educational materials
• Our medical writers will provide assistance with the document revisions
• Our clinical team will help to implement the revised study.

Meditrial will not only ensure your medical device complies with the MDR and Member States requirements, but that you ultimately achieve market approval.

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