The regulatory system in Europe needs to be improved to ensure the provision of affordable medical devices to patients. For example, approval times urgently need to be shortened. Any improvements must be evidence-based so as not to cause new problems. Scientific evidence requires a solid data base.
We ask you to create this basis through your "data donation". In this way, you will help to benefit from a better regulatory system yourself.
Here's how you can help:
The EU Medical Device Regulations (MDR, IVDR) are in force. This means that all manufacturers must reauthorize their products and new certificates must be applied for. The Notified Bodies need to be re-designated.
Currently, only a single-digit percentage of certificates have been converted. Under the MDR and IVDR, there are still significantly fewer Notified Bodies designated.
The notified bodies are completely overloaded. According to their statements, approval of all products is not possible until the end of the transition period of the EU regulations. For manufacturers, this means months of waiting; in the worst case, they cannot even find a notified body.
The manufacturers are thus threatened with a loss of sales that could jeopardize their existence.
Regulatory changes may be needed to address this problem. The research questions are thus:
The research team wants to find answers to these questions with the help of your data donation.
A description of the project with background and objectives can be found in this one-pager.
The project proceeds in three steps.
This will improve the regulatory system and thus achieve the goal of the project.