The new regulation for Medical Devices (MDR 2017/745, Which has been applied in parallel with the old regulation (93/42/EEC) since 2017, came into full force from May 26th 2021. Materials already approved in accordance with the old directive can continue to be purchased until 2025. The new regulations target requirements for updated documentation and risk analyses, as well as improved traceability of materials. It is important to ensure that materials and manufacturers comply with the new regulations, and that the manufacturers have implemented quality-assured management and manufacturing processes, and that these do not deviate from handling instructions and indications to the user.
Nytt regelverk för medicintekniska produkter i tandvården
Örtengren U, Hensten A
Tandläkartidningen 2021; 113(10): 56-9