News Archives - RIAP

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

benedetta — Mon, 03 Jul 2023 12:31:56 +0000

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 event).

To be updated on CORE-MD activities and events, please follow the project’s Twitter and LinkedIn profiles

Project funded by EU Horizon 2020 program – Grant 965246

Attachments

Training and education for regulators, for notified bodies and clinicians

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The article Fourth CORE-MD webinar: Training and education for regulators, for notified bodies and clinicians appeared first in RIAP.

Third CORE-MD webinar: Objective Performance Criteria

benedetta — Fri, 24 Mar 2023 09:35:11 +0000

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 be updated on CORE-MD activities and events, please follow the project’s Twitter and LinkedIn profiles

Project funded by EU Horizon 2020 program – Grant 965246

Attachments

Third CORE-MD webinar program

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The article Third CORE-MD webinar: Objective Performance Criteria appeared first in RIAP.

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

benedetta — Wed, 01 Mar 2023 12:01:46 +0000

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 event).

To be updated on CORE-MD activities and events, please follow the project’s Twitter and LinkedIn profiles.

The webinar video is available at the following link:

https://www.core-md.eu/core-md-webinar-replay-the-origins-and-the-objectives-of-the-medical-device-regulation/

Project funded by EU Horizon 2020 program – Grant 965246

Attachments

Second CORE-MD webinar program

Download pdf - 1.66 MB

The article Second CORE-MD webinar: The origins and the objectives of European regulation for medical device appeared first in RIAP.

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

benedetta — Fri, 27 Jan 2023 11:22:44 +0000

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 updated on CORE-MD activities and events, please follow the project’s social media.

The webinar video is available at the following link:
https://www.core-md.eu/core-md-first-webinar-available-in-replay/

Project funded by EU Horizon 2020 program – Grant 965246

Attachments

CORE-MD webinar program

Download pdf - 293.96 KB

The article CORE-MD webinar: Orthopaedic implants and European Medical Device Regulations appeared first in RIAP.

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

benedetta — Wed, 13 Apr 2022 13:47:52 +0000

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 RIAP had started, as part of the first of a series of agreements between the Italian Ministry of Health and the Italian National Institute of Health (ISS), aimed at developing a nationwide network to monitor hip, knee, shoulder and ankle joint replacements.

Since the establishment of the Italian Implantable Prostheses Registry (RIPI) in 2017, RIAP has been used as a model to setup registries of other implantable medical devices.

The article Italian Arthroplasty Registry (RIAP): paving the way for the monitoring of implantable devices in Italy appeared first in RIAP.

The European Medical Devices Regulation came into effect

benedetta — Fri, 04 Jun 2021 12:20:33 +0000

On the 26^th 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 as importers and distributors of medical devices.

The full MDR text is available here.

The European Commission provides more details:

The new Regulation is fully effective for the joint prostheses considered by the Riap.

The article The European Medical Devices Regulation came into effect appeared first in RIAP.

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

benedetta — Wed, 28 Apr 2021 10:42:07 +0000

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 close partnership with the European Federation of National Associations of Orthopaedics and Traumatology (EFORT). The Italian National Institute of Health (ISS) is one of 22 partners of the consortium involved in the development, evaluation, approval and certification, clinical use, and monitoring of medical devices. The members of RIPI working group (M. Torre, P. Laricchiuta, E. Carrani, S. Ceccarelli e F. Boniforti as a member of Riap Steering committee) are among the participating experts.

Attachments

CORE-MD press release

Download pdf - 278.88 KB

The article With CORE-MD project, EU assessment of high-risk medical devices faces in-depth review appeared first in RIAP.

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

benedetta — Wed, 31 Mar 2021 10:57:07 +0000

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, and regional health authorities. The study, involving 7 Regions, portrays and compares the number of arthroplasty operations in 2020 with data from 2018 and 2019.

To meet new healthcare demand caused by the COVID-19 pandemics, in March 2020 Italian Regions suspended elective surgery, in some cases beyond mid-June. The report presents the results of the analysis of the Hospital Discharge data until 30/09/2020 and lays the foundations for a more in-depth assessment of the effects of the emergency on patients. Furthermore, it describes the strategies of reorganization adopted by the participating Regions, as well as the experiences of some facilities from the point of view of the surgeons involved.

In the upcoming months, the report will be updated.

*Makes part of a series of reports “Rapporti ISS COVID-19” mainly addressed to healthcare professionals to cope with different aspects of the COVID pandemic. They provide essential and urgent directions for emergency management and are subject to updates.

Attachments

Rapporto ISS COVID-19 n. 7/2021 Rev - Impatto dell’emergenza COVID-19 sui volumi di attività della chirurgia protesica ortopedica in sette Regioni italiane

Download pdf - 6.13 MB

The article Impact of COVID-19 on volumes of orthopedic prosthetic surgery in Italian Regions: a new report appeared first in RIAP.

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

benedetta — Thu, 14 Jan 2021 09:37:34 +0000

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 Notiziario ISS (volume 33, n.12, 2020). Ten years after the founding of Riap, the article provides an overview of its development, its regulatory basis and its benefits for the national healthcare system. The article also reports the numbers of arthroplasty operations in Italy which see an average annual growth of 4.2% which makes the Register a necessary tool for patient protection.

The text is available in Italian.

The article Enhancing the achievements of the Italian Arthroplasty Registry: published in Notiziario ISS an overview of its development appeared first in RIAP.

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

benedetta — Tue, 09 Jul 2019 12:33:59 +0000

According to Article 26 of Regulation 745/2017 on medical devices and Article 23 of Regulation 746/2017 on in-vitro diagnostic medical device, the European Commission is required to make available a medical device nomenclature to support the functioning of the future EUDAMED (European Database on Medical Devices). We are pleased to inform you that The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature.”

Attachments

Download the official press release

Download pdf - 12.06 KB

The article European Commission: Italy’s CND replaces GMDN for DM nomenclature appeared first in RIAP.