In EU for medical devices and Software of Class 2b and Class 3 and Class 3 in USA/FDA have to prove that all criteria of the:
- MDR (Medical Device Regulation) https://thaumatec.com/knowledge/blog-posts/healthtech-knowledge-guide-healthtech-standard-highlights-mdr-iso/
- IVDR (In Vitro Diagnostics Medical Device Regulation) https://thaumatec.com/knowledge/blog-posts/healthtech-industry-update-in-vitro-diagnostics-device-ivd-regulation-implementation/
- FDA (United States Food and Drug Administration) https://thaumatec.com/knowledge/blog-posts/healthtech-knowledge-healthtech-standard-highlights-iec-fda/
is fulfilled.
One point in this Regulation is to undergo Clinical Trials (or Clinical Studies or Clinical Investigations).
The safety, function and value-add of the Devices must be Bench testing, Technical testing, Computer simulations, Animal studies must be checked and documented. Pre-clinical activities do not use human subjects in this case.
There are different pathways for the US and EU.
In the US, medical device manufacturers that want to pursue a clinical trial must obtain an Investigational Device Exemption (IDE).
Here as well a blog post by Thaumatec where you can have a look about the processing: https://thaumatec.com/knowledge/blog-posts/healthtech-industry-update-from-the-idea-to-a-medical-device/
In the EU MDR has 20 articles for clinical investigations of medical devices that are relevant. Within these articles, the regulation lays out three regulatory pathways manufacturers can take
During the premarket and postmarket phases of the device clinical trials may be executed.
Early Pilot studies
in the device development when nonclinical testing is unable to provide information on device functionality and clinical safety at this point of time.
Pivotal studies
are used to gather definitive evidence of the safety and effectiveness of your medical device for a specific intended use.
post-market surveillance
includes both confirmatory and observational types of clinical activities.
Observational clinical activities
Many post-market clinical activities are categorised as “observational” and they use non-interventional methods to collect data.
Some devices may need:
- clinical data from all of these categories
- many will not.
- low risk devices relying on well-known technology may not require any clinical investigations
Here a nice video about clinical trials globally…
And here an article “Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained” from Jon Bergsteinsson in Greenlight Guru:
https://www.greenlight.guru/blog/medical-device-clinical-trials
