flow-meter™ | The European regulatory system with the new MDR - part 1

The European regulatory system with the new MDR Regulation (EU) 2017/745 is based on the principles of the European New Legislative Framework developed in continuity with the New Approach principles of MDD Directive 93/42/EEC. The definition of this Regulation criteria stems from a number of significant adverse events that have occurred in the past decade and that have raised questions about the roles and responsibilities of the actors. The outcome had to be driven by the principle of raising the quality and safety standards of devices, while creating a sustainable legislative framework, conducive to innovation and improved safety of medical devices in Europe.
The New Regulation introduces the concept of the product's mechanism of action, which obliges the manufacturer to demonstrate its awareness of the intended use of the device, but above all of device functionality.
These concepts must be combined with the principle of absolute safeguarding of the patient user of the device, also highlighting the aspect of the product life cycle and the need to give evidence that the device is safe and can achieve and guarantee the expected performance.
The Regulation also introduces the position named Person Responsible for Regulatory Compliance, who covers civil and penal liability for technical, clinical, regulatory and product market launch responsibilities for each single device batch or part made available. This novelty therefore obliges manufacturers and distributors to include structured and specific resources and competences in their organizations, which is actually the case in the field of pharmaceuticals, in order to place the actors, present in the EU scenario, as recognized guarantors of the principles of safeguarding health at a global world level.
The governance of the free sales of medical devices and the control of supervisory activities by Notified Bodies and Competent Authorities must be supported by common approach tools, such as the establishment of EUDAMED and behavioral guidelines (NBOG and MDCG) that must be applied to Notified Bodies, Competent Authorities and, of course, manufacturers.
26 May 2021 was, formally, the date from which the full applicability of Regulation 2017/745 was to take effect. However, the non-operationality of EUDAMED, the costs and lack of resources required to ensure the activation of all the mechanisms provided for in the Regulation induces the recourse to transitional solutions by the Member States regarding the registration of devices and economic operators, certification notifications, vigilance and clinical investigations, as well as extensions of the due dates. As of 26.05.21, the derogation period began. In this period, the devices complying with the previous Directive could continue to be lawfully placed on the market as legacy devices. The recent transitional provisions, however, have been extended beyond the first end date of 26.05.2024, which was set when the provisions came into force.
More Information:
www.flowmeter.it
/ flow-meter-s.p.a .