Medical devices | WHOCC PPRI

In addition to its expertise in policies related to pricing and reimbursement of medicines, the Pharmacoeconomics Department has gained in-depth knowledge on medical devices through its involvement in numerous activites related to medical devices.

Regulatory activities

Medical devices include a variety of medical technologies and procedures such as syringes, pacemakers, and wheelchairs. In order to improve market surveillance in this area, the Medical Devices Act regulates that Austria has to keep its own register for medical devices as well as a register for testing, monitoring and certification bodies.

Austrian Register of Medical Devices

Gesundheit Österreich GmbH was commissioned in 2001 by the then Austrian Federal Ministry of Health to set up and maintain these registers. Since January 2002, the registration of medical devices and in-vitro diagnostics has only been possible on the website www.medizinprodukteregister.at and carried out by all companies or persons subject to registration in the form of a free of charge self-registration .

For further information: see Austrian Register of Medical Devices

European Database for Medical Devices (EUDAMED)

EUDAMED2

GÖG, together with the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection, acts as the national contact point for the European Database for Medical Devices (EUDAMED) and has been transmitting the Austrian data to the European database since May 2011. This allows a quick exchange of information between EU Member States, and it will be able to respond quickly to the safety risks of medical devices. Due to new EU regulations, a completely redesigned and more comprehensive European Database for Medical Devices (EUDAMED MDR/IVDR) is planned to replace EUDAMED2.

EUDAMED MDR/IVDR

On 5 May 2017, the EU Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) were published in the European Official Journal and entered into force on 25 May 2017. These two regulations also provide for the establishment of a European Database for Medical Devices (EUDAMED) to achieve their objectives.

The European Commission has made available the Actor registration module on December 1, 2020, which is the first of six EUDAMED modules . The Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG) has been commissioned by the Austrian Ministry of Social Affairs, Health, Care and Consumer Protection to validate the entries in the Actor registration module.

Policy work

More recently, the Pharmacoeconomics Department has been working on policy-related aspects of medical devices, in particular on prices and policies for pricing and reimbursement of medical devices.

A sub-group of the PPRI network on medical devices was established in 2018.

Study supporting the monitoring of availability of medical devices on the EU market

In December 2022, the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”.

The study has been contracted to a consortium led by GÖG, in collaboration with Areté and Civic Consulting with the aim to monitor and analyse the availability of medical devices on the EU market in the context of the implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market

Gesundheit Österreich GmbH (Austrian National Public Health Institute) in collaboration with Agra CEAS Consulting IHS Markit (now part of S&P Global), Areté and Civic Consulting were appointed by the European Commission (via its European Health and Digital Executive Agency / HaDEA) to carry out a "Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market".

Value Dx: Diagnostic policies to reduce AMR in CA-ARTI

GÖG is a partner in an EU project to fight antimicrobial resistance through diagnostics.

VALUE-Dx is an European project with 26 collaborating partners (it is an Innovative Medicines Initiative / IMI project, initiated by the European Commission). The project aims at generating evidence of the added value of diagnostics in order to tackle antibiotic resistance through a targeted use of antibiotics. The Pharmacoeconomics Department at GÖG is involved in the work package on “Economic Value, Policies and Innovative Funding Models” and analyses pricing and reimbursement policies of diagnostics.

Based on a transnational study and analysis of policy measures for the pricing and reimbursement of diagnostics for acute respiratory infections, a proposal for innovative pricing and reimbursement policies for these diagnostics will be developed.

In 2020, a comprehensive survey of existing pricing and reimbursement mechanisms for diagnostics, especially for acute respiratory infections, was carried out in European countries. Information from 16 countries were collected and summarised in a report.

https://www.value-dx.eu/

Policy options for antibiotics and diagnostics in the field of AMR

Gesundheit Österreich was commissioned by the Global AMR R&D Hub to investigate policy options to inform national policy-makers in addressing novel antibiotic and diagnostic reimbursement and purchasing.

The study aims to provide evidence on policy options for antibiotics and diagnostics in the field of Antimicrobial Resistance (AMR), which has become a complex issue of major global concern. In particular, the study aims to identify and assess policy options which can incentivise producers to invest in the development of novel antibiotics and diagnostics and thus contribute to ensuring resistant infections remain treatable for all patients.