Within the European project CORE-MD (Coordinating Research and Evidence for Medical Devices), in which the Italian National Institute of Health participates as a partner, the third Webinar entitled “Training and education for regulators, for notified bodies and clinicians” was held on Zoom on July 10, 2023, from 17.00 to 18.15 (attached, the program of the …
Within the European project CORE-MD (Coordinating Research and Evidence for Medical Devices), in which the Italian National Institute of Health participates as a partner, the third Webinar entitled “Objective performance criteria for medical devices” was held on Zoom on April 3, 2023, from 17.00 to 18.15 (attached, the program of the event). Registration link. To …
Within the European project CORE-MD (Coordinating Research and Evidence for Medical Devices), in which the Italian National Institute of Health participates as a partner, the second Webinar entitled “The origins and objectives of European regulations for medical devices” was held on Zoom on March 6, 2023, from 17.00 to 18.15 (attached, the program of the …
Within the European project CORE-MD (Coordinating Research and Evidence for Medical Devices), in which the Italian National Institute of Health participates as a partner, the first Webinar entitled “Orthopaedic implants and European Medical Device Regulations” was held on Zoom on January 30, 2023, from 17.00 to 18.15 (attached, the program of the event). To be …
The video describing the RIAP through a series of questions and answers is now available online. Together with Eng. Marina Torre (RIAP and RIPI Project Leader) we learn about the reasons that made RIAP a real forerunner in monitoring implantable devices, as well as its history, structure and future outlook. In 2006, the implementation of …
On the 26th of May 2021, the new Medical Devices Regulation (EU) 2017/745 (MDR) came into effect. Medical devices placed on the EU market must now comply with the MDR. After the transitional period and a delay due to the COVID-19 emergency, this is an important date for manufacturers and their authorized representatives, as well …
CORE-MD, the first European project to identify ways to enable the scientific, fair, and systematic evaluation of medical devices, has been officially launched on 16 April. More than 50% of high-risk implantable medical devices in Europe are used in cardiology and orthopaedics. The multidisciplinary project is led by the European Society of Cardiology (ESC) in …
The report “Impact of COVID-19 pandemic emergency on joint arthroplasties in seven Italian Regions. Version of March 17, 2021” (Rapporto ISS COVID-19 n. 7/2021*) is now available on the website of the Italian National Institute of Health in Italian language. The study is the result of a close collaboration between the RIAP working group, surgeons, …
The article “Valorizzare il patrimonio del registro italiano artroprotesi (Riap): un passo necessario per migliorare la qualità delle cure e la sicurezza del paziente” (Torre M, Urakcheeva I, Carrani E, Ciminello E) /Enhancing the achievements of the Italian Arthroplasty Registry: a necessary step to improve the quality of care and patient safety/ was published in …
The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature.