Support related to clinical investigation planning and execution for the EU and US markets is a common client request. The first step every medical device organisation must take is to determine whether a clinical investigation (sometimes referred to as a clinical trial) is required. If the safety and performance of the client’s device cannot be supported by the existing body of knowledge, then a clinical investigation will most likely be required.
Notified Bodies apply a risk-based approach and may accept animal studies and data from the existing scientific body of knowledge as part of the CE Mark submission, but they will insist that a Post-Market Clinical Follow-Up (PMCF) study be completed to verify the safety and performance of the device when launched to the market. This means that clinical investigations can occur before device approval and also after approval. The industry is seeing a trend where PMCF studies are becoming more frequent as the regulators tighten the clinical requirements. They no longer accept simple justifications for why a PMCF is not required. The EU Medical Device Regulation (EU MDR) includes very stringent clinical requirements and as an industry, we will need to conduct significantly more clinical investigations.
The US market has two main medical device approval routes. In a nutshell, the 510(k) process allows medical device organisations to gain approval to launch product in the US based on substantial equivalence to an existing US-approved device. The Pre-Market Approval (PMA) route is used for higher risk devices (in general Class III and new innovations that cannot claim substantial equivalence to previously approved US 510(k) devices) where clinical evidence to support the safety and effectiveness of the high-risk device must be gathered via a clinical investigation.
Any clinical investigation conducted must adhere to Good Clinical Practice (GCP) as per ISO 14155.
I have put together the following publicly available information that will prove useful to clients who wish to research their clinical investigation obligations.