After a period of transition and adaptation of medical devices manufacturers to the new rules, the new legislation will come into force on May 26, 2020. the goal is to increase the safety of the patients in dentistry.
Three years after the publication of the Medical Devices (DM) regulation and five years after the publication of the Medical Devices For Vitro Diagnostic (DIV) regulation, new rules will now come into force to improve surveillance, market surveillance and traceability, as well as ensuring that these products incorporate the latest technology. This changes also aim to ensure greater transparency and legal security for manufacturers, strengthening international competitiveness and innovation in the sector.
In this context, the various parties involved – manufacturers, distributors, users and competent authorities – are required by this legislative framework to comply with a number of obligations and procedures that must be observed, in particular in terms of clinical research and performance evaluation, classification, border demarcation, conformity assessment, market position, registration, notification, acquisition and use as well as supervision.
Contacted by DentalPro, some of the manufacturers are somewhat concerned about the new regulations. Find out why in the next issue.
