News

Fourth CORE-MD webinar: Training and education for regulators, for notified bodies and clinicians

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 …

READ MORE

Third CORE-MD webinar: Objective Performance Criteria

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 …

READ MORE

Second CORE-MD webinar: The origins and the objectives of European regulation for medical device

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 …

READ MORE

CORE-MD webinar: Orthopaedic implants and European Medical Device Regulations

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 …

READ MORE

Italian Arthroplasty Registry (RIAP): paving the way for the monitoring of implantable devices in Italy

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 …

READ MORE

The European Medical Devices Regulation came into effect

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 …

READ MORE

With CORE-MD project, EU assessment of high-risk medical devices faces in-depth review

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 …

READ MORE

Impact of COVID-19 on volumes of orthopedic prosthetic surgery in Italian Regions: a new report

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, …

READ MORE

Enhancing the achievements of the Italian Arthroplasty Registry: published in Notiziario ISS an overview of its development

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 …

READ MORE

European Commission: Italy’s CND replaces GMDN for DM nomenclature

The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature.

READ MORE