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Sorveglianza post-marketing

Post-Market Surveillance – PMS

Regulation (EU) 2017/745 on medical devices has introduced the definition of post-market surveillance (PMS):

All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.

Although such requirement was already present in Directive 93/42/EEC, Regulation (EU) 2017/745 has introduced further obligations for manufacturers, and those already existing are made more explicit.

In fact, it is clearly indicated that the PMS should be an actual system, integrated in a wider manufacturers’ quality system.

Such “sub-system” should include various activities, aimed at collecting information during the post-market phase. It should also be proportional to the risk class and appropriate for the type of device.

Di Renzo Regulatory Affairs has a special unit of qualified professionals that can assist clients in designing such system as well as in performing most activities

The main services offered are:

  • implementation of the PMS requirements for MDR and IVDR
  • drafting PMS documents (plan, report, PSUR, PMCF report)
  • PMS activities (e.g. control of databases, literature, etc.)
  • trend analysis
  • PMCF activities
  • vigilance
  • staff training.

Foto di DarkoStojanovic da Pixabay