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Let’s try to clear out all the mystery that stands behind this statement. We’ll start with its definition from the previous article where we have defined basic terms in the medical device industry:

Medical device manufacturers, as well as other companies involved in the distribution of devices, must follow certain requirements and regulations once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed.

As the medical device's complexity increases, post-market surveillance is getting more rigorous, so it can lead to earlier detection of potential failure at the end-user. To meet these needs, manufacturers should take a risk-based approach when considering clinical and medical device post-market surveillance requirements.

But what market surveillance means for you?

Once you place your medical device to market, it does not mean that your job with it has ended. When you start building your medical device, you are doing it in a way to be safe, effective, and of course useful for the end-user. You are doing it to help out the people in need of help, it doesn’t matter about what medical device we are talking about. But you are not going to help out that much if something goes wrong with your medical device while it’s in a use. Since such cases, unfortunately, do happen Medical Device Regulation and FDA came up with something called post-market surveillance.

Post-market surveillance is for your benefit too, not only for end-users of course.

European and American medical device market made sure that you MUST conduct post-market surveillance to be/stay compliant with the harmonized standards ISO 13485 and ISO 14971. Nothing is left to chance.

It doesn't matter how your medical device is classified. Maintenance of post-market surveillance it’s made to be part of the process.

PMS is a set of processes and activities used to monitor the performance of a medical device. Medical device manufacturers are required to follow certain requirements and regulations once a device is on the market. Each market has its own rules.

FDA Requirements

Medical devices manufacturers have to conduct PMS for devices:

  • That could cause significant harmful health consequences due to its failure
  • That is implemented within the body for more than one year
  • Who’s aim is to sustain or support life and are being used outside a facility
  • That is expected to have an important use in the pediatric population

The FDA can require a surveillance time up to 3 years and longer, and medical device manufacturers are required to comply with an order for PMS within one year of received notice.

The EU requirements

Medical device companies are required to provide a post-market surveillance plan for CE-marking. It has to be correctly documented in your Quality Management System. Practically, you are expected to connect your PMS with feedback and complaint handling, management review, risk management, Clinical evaluation, CAPA, etc.
Said in other words, your QMS procedures must be linked to your post-market surveillance. EU MDR requires that post-market surveillance be proportionate to the risk class of the device. Therefore, you should that your procedure covers different approaches that will allow you more rigorous PMS for higher-class devices.     
The results of post-market surveillance activities will have an impact on the PMS process during the device life-cycle management.

Conclusion

Since the US and EU market is getting more and more harmonized it’s crucial for you to be compliant according to post-market surveillance system so you can put your medical device on the market.

It’s not enough to get approved based on clinical trials, PMS gained its necessity because it provides more information about the safety and effectiveness of the medical device.

Comments (3)

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Yes, as it's mentioned in the article, everything has to be connected to your QMS procedures. Well explained. In general, I would unite both markets, the US and EU, but it's most likely will never happen.
I agree with you, Ryan, about the uniting US and EU. Maybe then there would be no corruption.
To jump to this matter, discussed in the comments, if you ask me I would "uniform" regulations for medical devices generally. OK, something for "informing" the country you're entering the market should exist, but in the principle, pre-market inspection would be the same.

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