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 reactively 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
Obelis European Authorized Representative Center (O.E.A.R.C.)
O.E.A.R.C. is comprised of a team of regulatory experts who maintain the latest communication and changes regarding the GPSD and other EU Directives that directly apply to your product. We maintain continual communication with the Competent Authorities and can keep you immediately informed of any information applicable to your product(s). We can assist you in introducing or maintaining your products circulation within the EU and guide you through the regulatory maze of product safety and requirements.
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