# Post-Market Surveillance: What You Must Keep Doing After You Ship

CE marking compliance doesn't end when the product ships. EU, UK, and US regulations require manufacturers to maintain active post-market surveillance — monitoring the field, investigating complaints, tracking failures, and acting on safety information that emerges after launch. Regulators expect documented PMS processes, and the absence of one is itself evidence of non-compliance during an investigation.


## Transcript

### Compliance is not a one-time event

Most hardware companies treat compliance as a project with a finish line: get the CE mark, ship, done. That's wrong. EU, UK, and US rules require active post-market surveillance for as long as you sell the product. Shipping is when the obligation begins.

### What PMS involves in practice

Post-market surveillance means tracking field data — complaints, failures, returns — to catch safety risks early. The EU's GPSR requires a proactive process. Find a serious risk, and you have three days to notify the authority.

### Building a minimum viable PMS process

Before launch, build three simple documents: a complaints log, a safety investigation procedure, and a corrective action record. A well-structured spreadsheet is enough for a small company. Assign one named person to own PMS, and review the log every quarter.

Tags: post-market surveillance, CE marking, compliance, product safety, EU