Please help improve the regulatory system!

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:

• Download Excel file
• Fill in at least one line for each approved product
• Send completed file to Dr. Manuel Baur (manuel.baur(at)johner-institut.de)
• For help and a description of all data fields, please refer to the Data Dictionary
   

a) Situation

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.

b) Complication

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.

c) Research question & solution approach

Regulatory changes may be needed to address this problem. The research questions are thus:

• What determines the length of regulatory approval processes (in the EU and the US)?
• What would need to be done to minimize them?

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.

1. Step: The manufacturer
   • download this Excel file,
   • fill in one line for each approved product in each of the three tabs (at least one line or one product; the more the better). Feel free to use the Data Dictionary for this, which describes all data fields, and
   • send the completed Excel file by e-mail to Dr. Manuel Baur (manuel.baur(at)johner-institut.de) of the Johner Institute.
2. Step: The Regulatory Scientists of the Harvard MIT Centers for Regulatory Science and the Johner Institute
   • evaluate this data,
   • present the results together with initial recommendations for action to stakeholders, such as the EU Commission or the working groups of the World Medical Device Summits ready and
   • publish the results in scientific journals.
3. The participants of the World Medical Device, especially the legislators and authorities,
   • then know which adjusting screws they need to turn in order to improve the regulatory system, and
   • can adapt the regulations accordingly and provide guidance on how to comply with them efficiently.

This will improve the regulatory system and thus achieve the goal of the project.