AGES is a government-owned agency attached to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection and the Austrian Federal Ministry for Agriculture, Forestry, Regions and Water Management. AGES executes federal state tasks in the areas of agriculture, food and feed safety control, control of infectious diseases, veterinary medicine, radiation protection, medical devices and pharmaceuticals.
AGES – Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
The Austrian Medicine and Medical Devices Agency (MEA) ensures that only safe and effective medicinal products and medical devices are available to the population in Austria, but also throughout Europe. To this end, it performs a wide range of tasks in connection with drug approval, clinical testing of drugs and medical devices, pharmacovigilance (drug safety), vigilance in the field of medical devices, and inspections. In the scope of AutoPiX, MEA contributes its experience of regulatory processes and is tasked with guidance for early regulatory interactions. Regulatory guidance will be developed to help AutoPiX partners on the road to the qualification of digital technology-based methodologies and to guarantee compliance with both MDR/IVDR and AI Act.

Q&A
In what part of the patient journey will your institution most likely contribute?
Our institution can probably contribute the most towards the end of the project, once the development has to fulfil the regulatory framework and gained regulatory visibility.
What long-term impacts do you envision of your contribution?
Earlier awareness of the regulatory requirements according to MDR/IVDR and AIR should increase the likelihood of realisation and find a real patient benefit in the application.
Why is it so important?
If the regulatory framework and its ongoing maturation (especially in AI) are ignored, patient benefit is less likely to be achievable.

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