Swissmedic Highlights Post-Market Surveillance Obligations for Legacy Devices
Swissmedic, the Swiss Agency for Therapeutic Products, has released findings from a recent focused action, underscoring the critical importance of robust Post-Market Surveillance (PMS) for all medical devices, including those classified as Legacy Devices (LDs). The review emphasizes that manufacturers must actively monitor the performance and safety of their devices throughout their lifecycle.
The Swissmedic review focused on Periodic Safety Update Reports (PSURs). These reports are crucial for proactively identifying potential risks and ensuring continued device safety and effectiveness.
Key Findings and Implications
The Swissmedic review highlighted several key areas needing improvement among manufacturers. While the specific details of these shortcomings are outlined in the full Swissmedic report, the agency is using the review to remind manufacturers of their obligations.
EU and Swiss Regulations Demand PMS for Legacy Devices
The announcement serves as a timely reminder that both European Union (EU) regulations and Swiss regulations require manufacturers to meet comprehensive PMS requirements for Legacy Devices. Despite these devices being on the market for some time, manufacturers are not exempt from the responsibility of actively monitoring their safety and performance. This includes:
- Systematic data collection: Gathering data from various sources, including user feedback, complaints, and scientific literature.
- Proactive risk assessment: Regularly evaluating potential risks associated with the device and taking appropriate corrective actions.
- Transparent reporting: Submitting timely and accurate PSURs to regulatory authorities.
Manufacturers who fail to meet these PMS requirements risk facing regulatory action, including device recalls and market withdrawals. Swissmedic emphasizes its commitment to ensuring patient safety and will continue to actively monitor compliance with PMS regulations.
Link to the Swissmedic Report: EN_Schwerpunktaktion_PSUR-final.pdf
Latest news
New MIR Form 7.3.1: Key Update for Incident Reporting under EU MDR
The European Commission has released a new version of the Manufacturer Incident Report (MIR) form which will become mandatory for all medical device manufacturers from November 2025.
EUDAMED Workshop: Essential Training for Medical Device Stakeholders
The European Commission is hosting a free, hybrid EUDAMED workshop in Stuttgart on May 21, 2025, designed to support the onboarding of all actors involved with the European Database on Medical Devices (EUDAMED).
EU Expands Harmonised Standards for MDR: Focus on Medical Gloves, Sterilisation, and Patient Transport Equipment
The European Commission has taken a significant step in strengthening the regulatory framework for medical devices by harmonising additional standards under the MDR.
-250x250.jpg&w=256&q=75)
MedNet EC-REP at CMEF Shanghai 2025
We are pleased to announce that we will be exhibiting at the China International Medical Equipment Fair (CMEF) in Shanghai from April 8 to April 11, 2025.
New Revision of MDCG 2020-16 Guidance on IVD Classification: Key Updates in Version 4
The Medical Device Coordination Group (MDCG) has released Revision 4 of the "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746" (MDCG 2020-16).
UK Updates Post-Market Surveillance Requirements for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices in Great Britain.
-250x250.jpg&w=256&q=75)
ISO 15223-1 Amendment: EC-REP Symbol Changes to EU-REP
The International Organization for Standardization (ISO) has recently amended ISO 15223-1:2021, introducing a change from "EC-REP" to "EU-REP" for the European Authorized Representative symbol.
%20(1)-250x250.jpg&w=256&q=75)
MedNet EC-REP at MedTec Japan 2025 – Meet Us at Booth 3303
We are pleased to announce our participation as an exhibitor at MedTec Japan 2025, one of Asia’s leading trade shows for medical device design and manufacturing. The event will take place in Tokyo from April 9–11, 2025.