Reporting Timelines
Manufacturers must report incidents within specific regulatory deadlines. The PMS plan and distributor contracts must account for:
- Immediate complaint notification requirements
- Time needed for incident assessment (serious vs. non-serious)
- Controlled communication with competent authorities
Regulatory Compliance Challenges
Regulatory surveys by Swissmedic and the Dutch IGJ have found that many device companies “are largely failing to live up to the expectations on which the Regulations are built”. Simply “copying and pasting” distributor obligations from Article 14 of the Regulations is insufficient—manufacturers must carefully tailor contract provisions to ensure enforceable support for PMS activities.
Privacy Considerations
Complaint data often includes sensitive patient information. Distribution agreements must include “appropriate privacy provisions with the manufacturer being controller of that complaint data so that the manufacturer can control its use, deployment, and deletion”.