Medical devices

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.

At the beginning of April 2019, the Federal Cabinet has adopted the draft of a "Law on the Establishment of an Implants Registry in Germany and other amendments to the Fifth Book of the Social Code” (Implants Registry Establishment Law, Implantateregister-Errichtungsgesetz, EIRD).

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in healthcare region Uppsala-Örebro. Currently, CAMTÖ is working on several assessments related to the medical devices and technologies such as equipment for 3D Printing, robot Intuitive daVinci Xi etc. After the completion of assessment procedure, the reports will be published at the web-site of Örebro County Council.

The Swiss innovation agency, InnoSuisse, reminds that the deadline for the application for financing of truly innovative projects is May 20, 2019. The Swiss Federal Council has ensured additional funding of CHF 24 million for 2019 and 2020 for the “Impulse digitalization programme.”

In April 2019, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published a quick report with indication criteria for cochlear implants in children.

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

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.

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.

On February 19, 2019 the new “Catalog of Goods and Services” for the centralized purchasing platform was presented to the regional health authorities by the Minister of Health. This new catalog includes up to 25,000 items, including drugs and health products.

In mid-February 2019, the French High Authority for Health (HAS) has published the new guideline to clinical evaluation of connected medical devices in France.

In January 2019, the Institute for the Hospital Remuneration System (InEK) has published the of medical devices and procedures approved for innovation funding (NUB). Out of 709 applications for drugs and technologies, 180 (25%) received the positive status 1, and 69 of them were the requests for the medical technologies.

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in January 2019. The decisions were made for eighteen medical devices.