EU Registry after getting CE marker under MDR

[SallyOV]

Hi,

Your comments and feedback would be greatly appreciated on the following points:

We are planning to conduct a registry in Italy following the receipt of the CE mark for a non-invasive Class IIa device. The device will be used within its certified intended use, and no additional burdensome tests are foreseen.

1. Based on my research, it appears that we will still need to obtain both Ethics Committee and Competent Authority (CA) approval. Could you confirm whether this understanding is correct?
2. As the clinical trial will be conducted at multiple sites across Italy, it seems necessary to identify the competent Ethics Committee for our application. Do you have any guidance on how to determine the appropriate Ethics Committee?
3. Could you confirm whether the clinical trial application to the Competent Authority must be submitted via the OsSC portal?

Many thanks in advance for your input. If you have any additional insights or feedback regarding clinical trials in Italy, I would be very pleased to hear them.

 

[Ronen E]

I'm confused. Why do you need to set up an official clinical trial if the device is duly CE marked and will be used within its certified intended use?

 

[SallyOV]

I'm confused. Why do you need to set up an official clinical trial if the device is duly CE marked and will be used within its certified intended use?

Hi,

thank you for your reply.

Actually, it's just a PMS study to collect additional real-world data during clinical practice. In Italy, however, it still appears to require Ethics Committee approval and notification to the Competent Authority.