Italy

20

May 2019

With the regional decree of April 23, 2019, Tuscany Regional Healthcare has published assessments of six medical devices belonging to various therapeutic areas, including a system for monitoring in heart failure, TAVI, glaucoma drainage system, intravascular lithotripsy system. Read more

06

May 2019

Italian Ministry of Health, together with the national HTA agency, AGENAS, has published two Horizon Scanning reports in December 2018. Public consultations are open until May 25, 2019. Read more

15

Apr 2019

With a regional decree of March 7, 2019, Tuscany Regional Healthcare has published assessments of seventeen medical devices belonging to various therapeutic areas. Read more

08

Apr 2019

In late March 2019, the Italian Minister of Health announced that the European Commission has decided to adopt the Italian national classification system for medical devices for the database at European level. Read more

02

Apr 2019

In late March 2019, the Italian Ministry of Health has published a new document on medical device governance. The document presents the guidelines for a new governance of medical devices, which aims at the efficient allocation of the NHS resources, the sustainability of innovation, the strengthening of supervision and the transparency of actions and reports concerning the procurement and use of medical devices. Read more

26

Feb 2019

In early February 2019, the entity that performs health technology assessment for medical devices in Italy, AGENAS, has called for the voluntary contribution of the clinical experts and/or reviewers, as well as for the participation of the manufacturers for announced that they’re working on several HTA projects on different medical devices and procedures, including bariatric surgery, continuous glucose monitoring, Elecsys®sFlt-1/PlGF test and others. Read more

09

Jan 2019

At the beginning of December 2018, the HTA entity of the Region of Tuscany has released a list of the upcoming assessments of the medical devices. Assessments include among others Impella ventricular assist device from Abiomed, Endocuff Vision colonoscope from Olympus, VascuFlex® Multi-LOC multiple stent delivery system from B Braun. Read more

12

Dec 2018

In late October 2018, Assobiomedica, the body that represents the companies that operate in the medical device sector, published the fourth edition of the document “Public policies for the purchase of medical devices.” Read more

07

Dec 2018

On November 7, 2018, the Italian Ministry of Health announced the document which should serve as a tool for the acquisition of medical devices through tenders. Read more

04

Dec 2018

On 7th of November, 2018, the Italian Ministry of Health announced that the technical standards for magnetic resonance and its use are updated. Read more

17

Oct 2018

On 3rd of October, 2018, the Italian Agency for Regional Healthcare Services, AGENAS, announced on their website that the reviewer volunteers are needed for reviewing the reports that should be published soon. Read more

11

Oct 2018

In the early July 2018, the authorities of the Italian region Veneto brought a decree that updates the regional guidelines for the management of patients with colostomy, ileostomy and urostomy that were published in January 2017. Read more