Is your Post-Market Surveillance System Proactive?

by | Jun 12, 2019 | FDA, Medical Devices, Pharmaceuticals, Quality Systems, Regulatory, Requirements

Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance – reactive and proactive. Reactive is the most common approach used when setting up a PMS system, but that doesn’t mean a proactive approach isn’t important. A good PMS system can become great by adding proactive measures to ensure only quality products are in the field.

Some proactive measures include customer surveys, manufacturer sponsored device tracking/implant registries, and expert user groups (focus groups).1 These measures are designed to get feedback on devices good or bad. Having more avenues to gather feedback allows issues to be fixed before large volumes of complaints are received. Additionally, with these extra avenues for feedback, opportunities for improvement may be identified that otherwise would not have been through the complaint process.

Monitoring clinical data via any of the above channels gives greater insight into how the device is performing on a day-to-day basis. These data can allow device developers and manufacturers to fine tune their devices quicker and more accurately, ensuring high performance and patient safety.

Presumably, these advantages are the reason why it is included in the EU MDR that devices’ clinical data must be reviewed and included in the technical documentation.2 Find more about what else is to be included in the technical file here: DO YOU KNOW WHAT YOUR TECH FILE SHOULD INCLUDE?

Having a proactive PMS system in place will soon be the gold-standard as the benefits to device quality and patient safety are great. How does your PMS system measure up?

Want to learn more about proactive PMS systems or EU MDR requirements? Need help establishing proactive measures in your existing PMS system? Contact us at 248-987-4497 or info@emmainternational.com.


1BSI –Effective post-market surveillance retrieved on 06/04/2019 from https://www.bsigroup.com/meddev/LocalFiles/en-US/Whitepapers/WP-Post-market-surveillance.pdf.

2BSI – Technical Documentation and Medical Device Regulation white paper retrieved on 06/06/2019 from https://www.bsigroup.com/globalassets/localfiles/es-es/Medical%20devices/Documentos%20tecnicos/white-paper-technical-documentation-web.pdf.

Jayme Brace

Jayme Brace

More Resources

De Novo Classification

De Novo Classification

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Abbreviated 510k submission

Abbreviated 510k submission

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