Regulatory Statement

Achieving CE marking for medical devices and in vitro diagnostic devices, in accordance with EU Regulations 2017/745 (MDR) and 2017/746 (IVDR), requires collaborative efforts from all stakeholders in the supply chain, from manufacturers to Notified Bodies, to ensure the devices' market entry.

There is a pressing need to enhance knowledge about the effectiveness and safety of medical devices through continuous interaction and dialogue with the European Commission, the Ministry of Health, and Industry Associations from the Health Care and Life Science sectors. By involving manufacturers, Notified Bodies, and healthcare professionals, we can ensure the clinical benefits of medical devices for the population.

At the moment, there is a widespread lack of awareness regarding the impact of MDR and IVDR Regulations, resulting in inadequate quality and quantity of documentation for medical devices. This leads to multiple revisions and challenges in communication between Notified Bodies and manufacturers.

A crucial aspect to consider is the role of clinical investigation in acquiring scientific data on the effectiveness and safety of medical devices. Unlike drugs, many manufacturers in Italy historically show reluctance in conducting clinical studies on their own medical devices. However, with the stricter requirements imposed by the MDR for demonstrating equivalence, it is increasingly difficult to rely on the CE marking of other medical devices already available on the market to obtain clinical safety and efficacy data.
Consequently, manufacturers may find themselves facing challenges in considering clinical investigations for their devices and establishing relationships with Ethics Committees for conducting such studies.
Currently, there is a significant lack of applications for clinical investigations on Medical Devices submitted to Ethics Committees.

PRINEOS, a strategic consulting firm in the Life Science and Healthcare sector, supports manufacturers on a daily basis to enable the market presence of medical devices and in vitro diagnostic devices, including innovative device designs.
Our dual in-house expertise in regulatory affairs and the design, planning, and execution of clinical investigations on medical devices allows us to guide manufacturers on the most appropriate path to achieve CE marking for their devices.

The European Union has granted an extension to the implementation deadlines initially set by the MDR and IVDR. This has resulted in different actions by manufacturers: while some have utilized the additional time for gathering clinical and safety evidence for their devices, others see it as an ongoing challenge.
Therefore, it is crucial to take action NOW to meet the deadlines and benefit from the extension. Acquiring knowledge about the nature and importance of clinical investigations with medical devices is essential.

PRINEOS embraces the state-of-the-art and promotes a Call to Action for manufacturers of Medical Devices and in vitro diagnostic devices.
We stand by manufacturers, understanding the necessary steps to be taken to make the CE marking process a reality. This includes deepening the documentation submitted to Notified Bodies and the significance of clinical evidence demonstrating the effectiveness and safety of the medical device.

Join us in ensuring safe and effective medical devices!