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January 10, 2026
Approximately 5 minutes
Frequently Asked Questions by Patients on Medical Devices in Switzerland – Swissmedic Overview
Frequently Asked Questions by Patients on Medical Devices in Switzerland – Swissmedic Overview
Purpose of the Patient Information Page
Swissmedic maintains a dedicated FAQ section for patients to address common concerns and misconceptions about medical devices used in Switzerland. The information helps patients understand their rights, device safety, and how the regulatory system protects public health under the Medical Devices Ordinance (MedDO). It covers everyday questions rather than technical regulatory details. Questions frequently asked by patients - Swissmedic
Common Topics Covered
Device Safety and Approval
- How can I check if a medical device is approved in Switzerland? Look for the CE marking (for most devices) or Swissmedic authorisation number (for higher-risk classes); many devices also carry a UDI.
- Are all medical devices safe? No device is completely risk-free, but approved devices undergo rigorous conformity assessment; Swissmedic monitors safety continuously.
Implants and Long-Term Devices
- What should I know about implanted devices (e.g., hip prostheses, pacemakers)? Patients receive an implant card with device details; keep it and inform healthcare providers; report any unusual symptoms.
- How long do implants last? Depends on the device and individual factors; follow-up with your doctor is essential.
Problems and Complaints
- What should I do if I suspect a problem with my device? Contact your healthcare professional immediately; serious incidents should be reported to Swissmedic (patients can report directly or via their doctor).
- Who is responsible if a device causes harm? Liability depends on the cause (manufacturer, healthcare provider, user error); Swissmedic investigates safety issues but does not handle compensation claims.
Recalls and Field Safety Actions
- How do I know if my device is affected by a recall? Manufacturers issue Field Safety Notices (FSNs) through healthcare providers; Swissmedic publishes relevant information on its website.
- What happens during a recall? Affected devices may need inspection, modification, replacement, or removal; follow instructions from your doctor or hospital.
Information Sources
- Where can I find reliable information? Swissmedic website, your healthcare provider, patient organisations, or the device manufacturer; avoid unverified online sources.
- Can I get information in my language? Swissmedic provides key information in German, French, and Italian; English versions are often available.
Key Messages for Patients
Swissmedic emphasises that patients should always consult healthcare professionals for personal medical advice. Reporting suspected problems helps improve device safety for everyone. The authority continuously monitors the market and takes action when risks are identified.
This patient-oriented FAQ resource promotes transparency, empowers patients to make informed decisions, and supports safe use of medical devices in Switzerland. Full list of questions, detailed answers, reporting forms, and additional links are available on the Swissmedic patient FAQ page. Questions frequently asked by patients - Swissmedic
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