Clinical and PMS studies
The definition and demonstration of the clinical benefits of a medical device, the verification of its clinical safety by evaluating any undesired side effects that may occur under normal conditions of use, require the collection of clinical data on the use of the medical device in the conditions provided by the Manufacturer.
The collection of such clinical data should be designed and conducted with clinical investigations or post-marketing follow-up studies. Medifocs supports companies in designing clinical investigation or post-marketing surveillance plans, taking into account the characteristics of the device.
As required by ISO 14155 “Clinical investigation of medical devices for human subjects – Good clinical practice”.
- Exploratory pilot studies: aimed at acquiring preliminary information on a medical device (at an early stage of its design, development and validation) in order to adequately plan further development phases. Exploratory clinical investigations may not require prior statistical assumptions. Pilot studies include “First in human clinical investigation” and “Early feasibility clinical investigation”.
- Confirmatory clinical Investigations: a confirmatory clinical investigation is a properly designed controlled clinical investigation with a predefined hypothesis for the primary endpoint and a statistical method for analysis.
- PMCF studies: are clinical investigations conducted on medical devices already approved and on the market, with the aim of answering specific questions related to clinical performance or clinical safety.
- Observational studies: are characterised by the absence of active intervention of the researcher who simply records (observes) what happens in reality. These are studies carried out on approved and marketed medical devices for a better understanding of their behaviour.
- Case reports: fall under the definition of descriptive clinical studies, they can provide supporting information about or illustrate specific claims but are limited to a non-large patient population.
- Surveys: are useful for establishing safety or performance issues or receiving quality feedback.
- Clinical studies for the approval of claims by the European Food Safety Authority (EFSA).
- Clinical studies to demonstrate effects on health or minimise a disease risk factor in accordance with Regulation (EC) 1924/2006.
- Clinical studies to confirm the validity of the indications for use.