Austrian BASG Consumer Guide to Medical Devices

1. What is a Medical Device?

A medical device is any product intended by the manufacturer for medical purposes in humans, achieving its effect primarily through physical means rather than pharmacological, immunological, or metabolic actions (unlike medicines). Devices range from simple items like band aids and contact lenses to complex ones like wheelchairs and rapid antigen tests. In vitro diagnostic devices (IVDs) test human samples outside the body. Within the European Economic Area (EEA), most devices must bear the CE marking, indicating compliance with safety and performance requirements. Source: BASG Medical Devices Consumer Page https://www.basg.gv.at/en/consumers/medizinprodukte

2. Role of BASG in Medical Devices

The Federal Office for Safety in Health Care (BASG) oversees the Austrian medical device market under the Medical Devices Act. Key activities include:

• Vigilance: Collecting and evaluating serious incident reports and corrective actions.
• Market surveillance: Ensuring compliance with legal requirements.
• Inspections: At manufacturers, representatives, and healthcare facilities.
• Classification and delimitation: Determining if a product is a medical device and its risk class.
• Exemptions and certificates of free sale. Source: BASG Medical Devices Consumer Page https://www.basg.gv.at/en/consumers/medizinprodukte

3. CE Marking and Labelling

CE marking confirms that the device meets essential safety and performance standards. Labelling must include product name, manufacturer details, lot/serial number, and instructions in German (or English for professionals). Common symbols are explained in a BASG poster. Source: BASG Medical Devices Consumer Page https://www.basg.gv.at/en/consumers/medizinprodukte

4. Vigilance System and Serious Incidents

The European vigilance system monitors device safety post-market. Serious incidents (those causing or risking death, serious health deterioration, or public health threats) must be reported by professionals and manufacturers to BASG. Consumers can report incidents via email to medizinprodukte@basg.gv.at, providing device and incident details. Source: BASG Medical Devices Consumer Page https://www.basg.gv.at/en/consumers/medizinprodukte

5. Consumer Reporting and Outcomes

Patients should first contact their physician or distributor. BASG confirms receipt and may request formal reports but does not disclose investigation outcomes due to confidentiality. Compensation or replacements are handled outside BASG scope. Safety notices and corrective actions are published on the BASG website. Source: BASG Medical Devices Consumer Page https://www.basg.gv.at/en/consumers/medizinprodukte

6. Contact Information

For inquiries: medizinprodukte@basg.gv.at Source: BASG Medical Devices Consumer Page https://www.basg.gv.at/en/consumers/medizinprodukte