Which statement about post-market surveillance in CE marking is correct?

Which statement about post-market surveillance in CE marking is correct?

• A. Post-market surveillance is required as part of CE conformity
• B. Post-market surveillance is optional
• C. It is not related to CE
• D. It is only for vaccines

Answer: (A)

Post-market surveillance is an ongoing obligation that ensures a medical device remains safe and effective once it’s on the market. When a device carries a CE mark, the manufacturer must have a post-market surveillance system in place to collect and evaluate data from actual use, identify new risks, and take corrective actions if needed. This keeps the device’s safety profile up to date and demonstrates continued conformity with EU requirements. It’s not optional, it isn’t unrelated to CE, and it isn’t limited to vaccines — it applies to all medical devices. That’s why the statement that post-market surveillance is required as part of CE conformity is the best description.

Post-market surveillance is an ongoing obligation that ensures a medical device remains safe and effective once it’s on the market. When a device carries a CE mark, the manufacturer must have a post-market surveillance system in place to collect and evaluate data from actual use, identify new risks, and take corrective actions if needed. This keeps the device’s safety profile up to date and demonstrates continued conformity with EU requirements. It’s not optional, it isn’t unrelated to CE, and it isn’t limited to vaccines — it applies to all medical devices. That’s why the statement that post-market surveillance is required as part of CE conformity is the best description.