Medical devices

On March 8, 2023, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic on the coverage of the INTERVAPOR system for lung volume reduction under Forfait innovation program.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 1756 of January 25, 2023, Tuscany Regional Healthcare has published assessments of two medical devices in the orthopedics, surgical procedures, and cardiovascular treatment areas.

On February 03, 2023, the first UKs medical technology (Medtech) strategy was published by the new Medtech Directorate at the Department of Health and Social Care. The strategy sets the government's ambition to accelerate access to innovative medical technologies, outlines the vision for Medtech, and defines priority areas for action.

On January 30, 2023, the Institute for the Hospital Remuneration System (InEK) published the list of the requests for innovation funding (NUB) that were submitted by the hospitals in 2022. The medical technologies belonging to the cardiovascular, eHealth, gastrointestinal, neuromodulation, neurovascular, peripheral vascular, orthopedic, and other technology groups obtained positive status 1.

On January 3, 2023, the Federal Joint Committee (G-BA) initiated the evaluation procedure concerning the method of renal denervation using ultrasound ablation in treatment-resistant hypertension (Paradise-System™ by ReCor Medical) within the framework of the early benefit assessment (in line with § 137h SGB V).

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 24486 of December 7, 2022, Tuscany Regional Healthcare has published assessments of three medical devices in the surgical procedures, neurology and neurosurgery, and extracorporeal treatments areas.

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in November 2022. Twenty recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular, neurovascular and neuromodulation, endocrine, ENT, endoscopic and dermatological devices, as well as devices for men’s health and medical aids.

In November 2022, Swedish Medical Technologies Product (MTP) Council issued a policy of proven experience for medical technology, which complies profession's assessment of how appropriate medical technology is in specific conditions. The policy provides some examples of how the MTP Council acquires knowledge of proven experience and its impact on the MTP Council's recommendations.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 21738 of November 4, 2022, Tuscany Regional Healthcare has published assessments of three medical devices in the orthopedics, surgical procedures, and peripheral vascular areas.

In November 2022, NHS England defined a deadline for applications to the High Cost Device List (HCDL) changes to be implemented in the 2024/25 National Tariff Payment System. The completed application form should be submitted via email by May 31, 2023.

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in October 2022. Fourteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular, neurovascular, orthopedic, and ENT devices, as well as medical aids.

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in September 2022. Thirty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular and peripheral vascular, neurovascular and neuromodulation, orthopedic, endocrine, ENT, dermatological, and spine-related devices, as well as digital care and medical aids.