Obelis European Authorized Representative Center
"CE Marking Consultants with a Reputation for Excellence"Post Market Surveillance
The European Commission obliges all manufacturers to have in place a Post Market Surveillance System as referred to in General Product Safety Directive (crossing Personal Protective Equipment, Low Voltage Devices, Toys, Devices emitting Electromagnetic waves, and Cosmetics) Article 5, the Medical Device Directive Annexes II-VII, and In-Vitro Device Directive Annexes III, IV, VI and VII.
In regards to P.M.S., the European Commission defines it as a way “to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times” MEDDEV 2.12-1 rev 4 April 2001.
Conducted either proactively or retroactively PMS can take the form of:
- Focus Groups
- Customer surveys
- Customer complaints and warranty claims
- Post CE-market clinical trials
- Literature reviews
- User feedback
- Device tracking/implant registries
- User reactions during training programs
- The media
- Experience with similar devices made by the same or a different manufacturer
- Maintenance/service reports
- Retrieval studies on explants or trade-ins
- In-house testing
- Failure analysis
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