Medical Device Regulation in Austria
Austria regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745) as a member state of the European Union. The Federal Office for Safety in Health Care (BASG) serves as the national competent authority. Austria has a well-established medical device industry and is fully integrated into the EU's harmonized regulatory framework.
Recent Regulatory Updates
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Non-CE-marked iCare STD self-tests banned in EU
Counterfeit needle-free IV connector alert issued
Counterfeit Sculptra batch 5J0406 warning issued
Sources Tracked by Qalico
Qalico continuously monitors 0 references across guidelines, regulations, and standards for Austria.
Device Classification
Austria follows the EU MDR classification system based on risk. Class I devices are low risk (e.g., stethoscopes, wheelchairs). Class IIa devices are low-moderate risk (e.g., hearing aids, ultrasound equipment). Class IIb devices are moderate-high risk (e.g., ventilators, X-ray machines). Class III devices are high risk (e.g., coronary stents, total joint replacements). Classification rules are defined in Annex VIII of the EU MDR.
Official classification guidance →Official Regulatory Bodies
Official Guidance Documents
Official information from Austria's competent authority on medical device regulation, registration, and vigilance reporting.
The complete text of EU Regulation 2017/745 on medical devices, which is directly applicable in Austria.
The European database for medical devices, used for device registration, UDI, and certificate information across all EU member states.
Standards & Key Principles
Applicable Standards
Key Principles
- Medical devices must bear the CE mark and comply with EU MDR 2017/745 before being placed on the Austrian market.
- Manufacturers must register their devices in EUDAMED and assign Unique Device Identifiers (UDI).
- Higher-risk devices (Class IIa, IIb, III) require conformity assessment by an EU-notified body.
- An EU-based authorized representative is required for manufacturers outside the EU.
- Clinical evidence and a clinical evaluation must demonstrate safety and performance for all device classes.
Pre-Market Requirements
Manufacturers must demonstrate conformity with EU MDR 2017/745, obtain CE marking, and for Class IIa and above involve a notified body in the conformity assessment process.
Complete technical documentation as specified in EU MDR Annexes II and III must be prepared, including device description, design and manufacturing information, risk analysis, and clinical evidence.
A clinical evaluation per EU MDR Article 61 and Annex XIV is mandatory for all device classes. For Class III and implantable devices, clinical investigations may be required.
Manufacturers must register in the European Database on Medical Devices (EUDAMED), including actor registration, UDI/device registration, and certificate data.
Post-Market Requirements
Manufacturers must implement a PMS system proportionate to the risk class. For Class IIa, IIb, and III devices, a periodic safety update report (PSUR) is required.
Serious incidents and field safety corrective actions must be reported to BASG in accordance with EU MDR Article 87. Trend reporting is also required.
PMCF activities must be conducted as part of the clinical evaluation to continuously confirm safety and performance throughout the device's lifecycle.
International Recognition & Reliance
As an EU member state, Austria's CE-marked devices are accepted across all EU/EEA markets under mutual recognition.
Under the updated Swiss-EU Mutual Recognition Agreement, CE-marked devices from EU member states including Austria are recognized in Switzerland with certain conditions.