Post Market Surveillance PMS highlighted

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Post-Market Surveillance (PMS) is a collection of activities that the manufacturer must perform to monitor the safety and performance of his product once this product is on the market. The purpose of this is that the manufacturer always has up-to-date information on the basis of which he can improve his product or its safe application if it proves necessary.
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New European legislation will enter into force in 2020. This describes the obligation for the manufacturer to perform PMS in more detail. PMS by manufacturers is essential to guarantee the quality and safety of medical devices.

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Responsibility
Manufacturers themselves are responsible for properly monitoring these risks and benefits and ensuring product safety. Following some reports, the inspectorate conducts an investigation or takes enforcement measures.

Healthcare professionals and/or patients
Experiences of healthcare professionals and/or patients when using the product may be a reason for further investigation by the manufacturer. This may mean that the manufacturer must then take necessary corrective or preventive measures.

Vigilance
Vigilance (monitoring) means the activities associated with detecting, assessing, understanding and preventing harmful side effects of medical devices. Vigilance is part of post-market surveillance.

In the Netherlands
The Healthcare and Youth Inspectorate (IGJ) assesses the extent to which manufacturers implement PMS and whether that complies with legislation.

For contact and information:

Roel de Vroege PhD
E: r.devroege@hb.vandelft.tech
T: +31  70 210 53 51

Visiting address:
Hagaziekenhuis
Els Borst-Eilersplein 275
2545 AA Den Haag

Relevant CV Roel de Vroege concerning PMS

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