Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities.

For the European Union (EU) market, the European Commission (EC) requires manufacturers to perform ongoing postmarket surveillance (PMS) activities once a device is placed on the market. This surveillance monitors for any potential safety or efficacy issues with the device, but it also allows manufacturers to be proactive when it comes to protecting patients.

By gathering customer feedback and other PMS data, manufacturers have an opportunity to proactively make improvements to their product or processes and prevent issues from arising in the first place.

The details of each PMS system may differ slightly from company to company, but if you plan on selling your medical device in the EU, your system must include these five components.

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