Clinical investigation after getting CE mark under MDR (patient involved)

[Rahim]

Dear all,


Your comments are warmly welcome on this topic:


I am working as an RA coordinator in a hospital in Germany. We have various customers who come to us for clinical trials involving patients.


My question is: If a device has a CE Mark under the MDR and the manufacturer wants to conduct clinical investigation on a patient in the hospital, is the manufacturer required to obtain ethical approval and inform the national competent authority?

Best regards,

Rahim

 

[Ed Panek]

I am not certain but in the USA the determination is first made "Is this a high risk study?" In some cases regulators permit the local authority to manage the outcomes if its lower risk. In the case of higher risk trials I believe there are reports that need to be made periodically to a higher authority than local.

What are the potential outcomes of this study? Death or serious harm? That will likely answer your path forward.

 

[Rahim]

Hi Ed Panek,

Thanks for your comment. The potential outcomes of this study is not death and serious harm. Its risk class IIa under MDR.

 

[dgrainger]

It's very unusual to undertake a clinical investigation on a single patient as it won't be statistically powered.

 

[Raisin picker]

As long as the device is used within the certified intended use, and no burdensome additional tests are performed, a PMCF trial in Germany does not require EC or CA approval. The principal investigator is, however, expected to consult his EC ("Standesrecht").

 

[Billy Milly]

As Raisin wrote above, if you are staying within the MD's indications, this is a PMCF not requiring approval (but still requiring informing of the CA in some member states). If you use the device outside its indications, this is a clinical trial, practically the same as for a new, uncertified device.

 

[Rahim]

As long as the device is used within the certified intended use, and no burdensome additional tests are performed, a PMCF trial in Germany does not require EC or CA approval. The principal investigator is, however, expected to consult his EC ("Standesrecht").

Hello Raisin picker,

Many thanks for your informative reply

 

[Rahim]

As Raisin wrote above, if you are staying within the MD's indications, this is a PMCF not requiring approval (but still requiring informing of the CA in some member states). If you use the device outside its indications, this is a clinical trial, practically the same as for a new, uncertified device.

Dear Billy,

Thank you for your comment