Fundamentals of Post-market Surveillance

What is Post-market Surveillance?

Post-market Surveillance (PMS) is the English term for the surveillance of medical devices and in-vitro diagnostics (IVDs) after they have been placed on the market.

Manufacturers of medical devices and IVDs operate in a strictly regulated environment. This is important because medical technology involves human lives. It’s about benefiting patients and not unnecessarily endangering them.

So, how do you verify, even after product development, whether medical devices on the market function as intended? How do you verify that they truly don’t pose unnecessary risks or even cause harm? It’s also entirely possible that the product itself is safe – but an error crept in during the manufacturing of a batch.

This is precisely where post-market surveillance comes into play. Manufacturers are obliged to establish a system that allows for the identification and evaluation of such adverse events in the market. These data must then be used to implement appropriate measures to ensure that medical devices and IVDs do not pose an unacceptable risk.

In short, PMS is an important tool for patient safety and the continuous improvement of medical devices.

What Does ‘Placing on the Market’ Mean?

This is defined by the two new EU regulations, MDR and IVDR: It refers to the first-time making available of a product on the EU market. Making available on the market refers to any supply of a product for distribution, consumption, or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

What is Post-market Surveillance about?

Data from various sources must be collected and evaluated. Such sources can be very diverse. Essentially, anything that contains information about the use of the medical device or IVD is suitable.

Possible sources include, among others:

• Published clinical investigations (other clinical investigations according to MDR)Complaints or other feedback from the marketPublicly accessible databasesSocial media channelsTelevisionAnd more
• The number of possible sources is enormous, because safety-relevant aspects of a product can be reported everywhere.

The major challenge in PMS is selecting suitable sources and meaningfully analyzing the large amount of data.

PMS data can even originate from other products. If a manufacturer has problems with their product on the market and you distribute a similar product, perhaps even using the same suppliers, then you should definitely check whether the same problems could occur with your own product. PMS can also be used for this purpose.

Why Do We Suddenly Have to Do all this?

Essentially, PMS is not new at all. The requirements already existed under 93/42/EEC (MDD) and 98/79/EC (IVDD) and their associated guidance documents, etc.

However, many manufacturers have not truly complied with the applicable requirements until now, and with the transition to (EU)2017/745 (MDR), many are realizing how significant the gaps are. This quickly creates the impression that the requirements in the area of post-market surveillance have increased significantly.

What’s Really New about it?

The MDR and IVDR require the generation of certain reports that were not previously necessary. These reports are based on the risk class of the products, and accordingly, different requirements apply to them.

More details will follow in later blog posts on the topic of PMS.

Why is there Such a Hype around this Topic?

On the one hand, it’s because many manufacturers are now realizing that their PMS processes do not comply with the requirements of MDR and IVDR. On the other hand, it’s due to some consultants who like to warn about the enormous complexity of the topic, creating uncertainty about how difficult the implementation is.

No advance is so difficult as the return to reason.

– Bertholt Brecht

What Does Thinqbetter Advise?

The topic is very important, no question. It should not be underestimated, but also not dramatized. An objective, well-considered approach and expertise are a good start. Subsequently, a gap analysis can clearly determine how well one’s own process covers the applicable and upcoming requirements.

Furthermore, our following blog posts will further address the topic and make it more understandable.

Post-market Surveillance and the Manufacturer’s Responsibility

Anyone who manufactures medical devices bears a great responsibility. This responsibility is not met simply by avoiding errors during development and production. Even if these areas function well, the medical device on the market can be associated with problems that were not previously considered.

To truly fulfill the responsibility of a medical device manufacturer, a robust post-market surveillance system must be implemented and continuously maintained.

A reputable medical device manufacturer cannot afford the motto that if problems are not (officially) known, then they don’t exist.

Incidentally, PMS is not just about identifying adverse events. In our experience, manufacturers often gain positive insights. For example, the product may be successfully used for other, previously unconsidered applications. Therefore, an expansion of the intended purpose can be considered, potentially attracting more customers to the product.

Even if difficulties with a product are observed in the field, it is not a disgrace. Quite the opposite: It’s an opportunity to make the product even better. It’s an opportunity to fulfill the responsibility as a medical device manufacturer and to demonstrate an understanding of the core principle of quality management – continuous improvement.

How Complex is Post-market Surveillance?

That depends on many factors. The most important one is your procedure or process for conducting post-market surveillance. If the process is not optimal, it either creates unnecessary workload or your PMS measures are simply not effective. You then have a process that is neither effective nor efficient. Please do not work with such a thing!

Assuming you have a good process that enables efficient and effective work, then, within the framework of creating PMS and PMCF plans, it is up to you to adapt the measures to your product and the associated risk. Depending on how thoroughly your process describes this, it requires more or less initiative.

In many cases, it is advisable to apply the same measures within a product group. Fundamentally, during planning, you should consider from which sources you can obtain data about your product or how you can generate it.

In summary, you need a good process and trained personnel who can create meaningful PMS and PMCF plans. This way, you can keep the effort as low as possible while still achieving maximum output.

Where should You Start?

Let’s assume you have decided to revise your PMS process according to MDR or IVDR. Where should you start?

PMS under the new regulations is not fundamentally new. There are some differences in the reports to be generated, but the basic steps are the same.

• Consider a structure. Which work steps need to be carried out?
• Identify applicable regulatory requirements and guidelines
• Review what measures you have implemented in the company so far (e.g., how was PMS done previously? Were Post-market clinical follow-up (PMCF) measures carried out to generate clinical data after placing on the market?
• What ambiguities or opportunities for improvement do you see in your current PMS system?

It is often advisable to attend a training course before all these steps. Let an expert explain what post-market surveillance entails and what steps are necessary. If you now start to familiarize yourself with the topic, it will be much easier for you.

Build a Fundamental Understanding

That’s easier said than done. The topic is complex, there are many ambiguities, and it is indeed regularly suggested that PMS will become very demanding, especially under the MDR and IVDR. How can one concentrate on the essentials then?

We’ll summarize it for you briefly:

• You manufacture medical devices and place them on the market. Your products are therefore on the Union market and are, for example, used by doctors to treat patients.
• You want to find out if these products function on the market as intended by you.
• You make a plan to approach the matter in a structured way.
• During planning, you consider how you can obtain data about your product and its use on the market.
• Then you collect this data from the planned data sources.
• You analyze and evaluate the data.
• Do the data show that there were problems with the product? Then you derive measures, e.g., a consideration of previously unknown risks within the framework of risk management.
• Now you create a report on the activities.

Congratulations, you have just completed post-market surveillance for one of your products!

In reality, there are, of course, some other aspects to consider, especially with regard to the MDR and IVDR. By and large, however, PMS works exactly by regularly carrying out the steps mentioned above and thus ensuring that available data is regularly collected, evaluated, and used.

We will go into more detail on Post-market clinical follow-up (PMCF) in a future post. Until then, please don’t worry: Because PMCF is not that bad either. You just need to know how it works.

Until the next post!