WHITEPAPER AND PRESS

Italy has recently instituted substantial changes in the national legislation on the supervision of medical devices in order to align our procedures with the European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics. 

Research and innovation are based on rigorous clinical trials involving patients firsthand. The main actor in clinical trials is the patient affected by the disease under examination. Including the patient’s perspective allows us to reduce barriers that otherwise limit your participation and to introduce tools and support that provide patients with the best possible experience. 

If well designed, observational studies and registries produce treatment effect data comparable in importance to those in randomized controlled trials, generating information missing in traditional interventional studies and real-world data to support marketing authorization.

After more than 20 years, new legislation, the “Medical Device Regulation” (EU-MDR 2017/745), has come into force in Europe. The triggers for the initiation and implementation of this European law, which is much stricter than previous directives, were scandals related to the safety of medical devices because they required a second surgery in a very large number of patients.

Research and innovation are based on rigorous clinical trials involving patients firsthand. The main actor in clinical trials is the patient affected by the disease under examination. Including the patient’s perspective allows us to reduce barriers that otherwise limit your participation and to introduce tools and support that provide patients with the best possible experience. 

The organization called ICH (International council for harmonization of technical requirements for pharmaceuticals for human use) is a global organization that unites regulatory authorities and the pharmaceutical industry in the common goal of ensuring the development of high-quality medicines. The ICH publishes numerous guidelines used internationally for the clinical development of pharmaceuticals.

When novel drugs or medical devices are evaluated in clinical trials, the data generated in this process is called clinical data. Improving the use of technology in clinical trials is now a prime opportunity for the life sciences industry. Digital trial processes enable us to automate operational decisions, which in turn can improve efficiency and site-centricity.

Recently, medical device security has become a global concern and a focal point for regulators and manufacturers. In Europe, among the many innovations introduced by new regulations for in vitro medical and diagnostic devices, pressure is emerging on regulators to ensure that products placed on the European Union market are adapted to new technological challenges related to cybersecurity threats.

In recent years, the field of biomarkers in research and clinical practice has shown remarkable progress. These tests can be used in the screening, diagnosis, characterization, and monitoring of diseases. The identification of reliable biomarkers can contribute strongly to the development of new
therapies and increase the success rates of clinical trials.

The International medical device regulators forum (Imdrf), describes Software as a Medical Device (SaMD) as software that can run on generic (non-medical) computing platforms. SaMDs represent a revolution in digital health technology that can perform complex medical functions, diagnose conditions, indicate treatments and support clinical management.