Article 84

Article 84 focuses specifically on the plan that will influence and determine the design of the post-market system.

The plan must include:

• Any information related to serious incidents;
  • This includes psur or fsca findings;
• Any records that refer to non-serious incidents or undesirable side-effects;
• Any information gleaned from trending reports;
• Any information from users, distributors, or importers;
  • This includes feedback or complaints; and
• Any publicly available information about similar devices;
  • This requires pro-active search and investigation.

The Final Design

The final design must be capable of proactively and systematically collecting and analyzing the data from above and draw conclusions based on comparison to expected performance characteristics of the products or devices, and to any similar products or devices on the market.

It is expected that the methods and processes used to assess the data collected, and to draw conclusions and recommendations, are based on formalized procedures and protocols.

Any recommendations on corrective or preventive actions should form part of the company’s PMCF plans or, if no plan is going to be developed, reasons and justification as to why not.