Die Marktüberwachung spielt eine zentrale Rolle bei der Gewährleistung der Sicherheit und Leistung von Medizinprodukten. Sie stellt sicher, dass Produkte nach der Zulassung weiterhin den Anforderungen der EU-Medizinprodukteverordnung (MDR) entsprechen und keine Gefahr für Patienten, Anwender oder Dritte darstellen. Durch die Marktüberwachung werden potenzielle Risiken identifiziert, Rückrufe durchgeführt und Maßnahmen ergriffen, um die Sicherheit von Medizinprodukten zu gewährleisten.
Market surveillance plays a central role in ensuring the safety and performance of medical devices. It ensures that products continue to meet the requirements of the EU Medical Devices Regulation (MDR) after they have been authorised and do not pose a risk to patients, users or third parties. Market surveillance identifies potential risks, recalls and takes action to ensure the safety of medical devices.
As a manufacturer, you must plan and carry out these market surveillance activities and prepare the corresponding reports. A distinction is made between a clinical report and a safety report, which must be prepared. The type and frequency of the reports depends on your product and its risk class.
BEO BERLIN can support you in the planning, implementation and preparation of market surveillance in the following areas, among others:
- Periodic Safety Update Report (PSUR) (medical device class IIa, IIb and III)
- Post-market surveillance report (PMS)
- Post Market Clinical Follow-up report (PMCF)
Market surveillance is an ongoing task that must be carried out in a structured and responsible manner. Do you need qualified external support?
