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Post-Market Surveillance requirements under the new European Medical Device Regulations

In the current Medical Device Directives, Post Market Surveillance is defined in Chapter I, Article 2, (40a), as the action requiring Medical Device Manufacturers to “proactively collect and review experience gained from their devices placed on the market.”

With the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, new requirements impacting Post Market Surveillance (PMS) have raised interrogations amongst Medical Device Manufacturers. While a continuous evaluation and improvement of the process is at the very heart of this change, the Regulations introduces more incisive and prescriptive measures based on device risk level for both the MDR and IVDR.

While Post Market Surveillance was always a regulatory requirement, the new measures introduced require that manufacturers follow on specific directions, tightening the links between PMS activities and other processes. Few examples of these new measures are: the issuance of Periodic Safety Update Reports (PSURs) to Notified Bodies, the update of the Vigilance and PMS procedures per the new requirements, and the increased involvement of Notified Bodies and authorities in the process.

Combo Training ISO13485 MDSAP

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Transition to ISO 13485:2016

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