- Post-market Surveillance
- 17. January 2023
Fundamentals for post-market surveillance
Lukas Losigkeit
CEO & Principal Consultant
What is post-market surveillance?
Manufacturers of medical devices and IVDs operate in a strictly regulated environment. This is important because medical technology is about human life. It is about serving the patient and not endangering them unnecessarily.
So how do you ensure that the medical devices work as intended in the market? How do you ensure that they really do not pose an unnecessary risk or even cause damage? It may well be that the product itself is safe - but a mistake has crept in during the production of a batch.
This is exactly where post-marketing surveillance comes into play. Manufacturers are obliged to set up a system that makes it possible to detect and evaluate such adverse events on the market. This data must then be used to implement appropriate measures to ensure that medical devices and IVDs do not pose unacceptable risks.
In short, PMS is an important tool for patient safety and the continuous improvement of medical devices and IVDs.
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 a product is made available on the EU market. Making available on the market means any supply of a product for 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 quite different. Basically, anything that contains information about the use of the medical device or IVD is suitable.
Possible sources are, among others:
The number of possible sources is enormous, because safety-relevant aspects of a product can be reported everywhere.
The big challenge in PMS is to select suitable sources and to analyze the large amount of data in a meaningful way.
PMS data can even originate from other devices. If a manufacturer has problems in the market with his product and you sell a similar product,you possibly even have the same suppliers, then you should definitely check whether the same problems could occur with your own device. PMS can also be used for this.
Why do you suddenly have to do all this?
Basically, PMS is nothing new. The requirements already existed under the 93/42/EEC (MDD) and 98/79/EC (IVDD) as well as associated guidance documents etc.
Up to now, however, many manufacturers have not really complied with the applicable requirements, and with the changeover to (EU)2017/745 (MDR), many people are noticing how big the gaps are. This quickly gives the impression that the requirements in the area of post-market surveillance have increased considerably.
What's really new about it?
The MDR and IVDR require the generation of certain reports, which were not necessary before. These reports are based on the risk class of the products and are therefore subject to different requirements.
More details will follow in later blog posts on the topic of PMS.
Why is there such a hype about this topic?
On the one hand, it is related to the fact that many manufacturers now find that their PMS processes do not meet the requirements of MDR and IVDR. On the other hand this is due to some consultants who like to warn about the enormous complexity of the topic. They warn about how difficult the implementation is and create uncertainty.
No advance is as difficult as the return to reason.
- Bertholt Brecht
What does thinqbetter advise?
The subject is very important, no question. It should not be underestimated, but neither should it be dramatised. An objective, considered approach and expertise are a good start. Then a gap analysis can clearly determine how well your own process covers the current and future requirements.
In addition, our following blog posts will cover the topic further and make it easier to understand.
Post-market surveillance and the responsibility of a manufacturer
Anyone who manufactures medical devices carries a great responsibility. This responsibility is not fulfilled by the fact that no mistakes should be made during development and production. Even if these areas function well, the medical device may be associated with problems in the market that were not previously taken into account.
In order to truly meet the responsibilities of a medical device manufacturer, a sound post-market surveillance system must be implemented and sustained.
The motto, if problems are not (officially) known, then they do not exist - a serious manufacturer of medical devices cannot allow this.
By the way, PMS is not only about identifying adverse events. In our experience, it is often the case that manufacturers gain positive insights. It happens, for example, that the device is successfully used for other applications that were not previously considered. It is therefore possible to think about extending the intended use of the product and, if necessary, to win over new customers for the device.
Even if difficulties with a device are observed in the field, this is not a disgrace. On the contrary: it is a chance to make the product even better. It is a chance to live up to the responsibility as a medical device manufacturer and to show that you have understood the core idea of quality management - continuous improvement.
How complex is post-market surveillance?
This depends on many factors. The most important one is your standard operating procedure or process for carrying out post-market surveillance. If the process is not optimal, it either creates unnecessary work or your PMS measures are simply not effective. You have a process that is neither effective nor efficient. Please do not work with something like this!
Suppose you have a good process that allows you to work efficiently and effectively. Then it is up to you to adapt the measures to your device and the associated risk when creating PMS and PMCF plans. Depending on how detailed your process describes this, this requires more or less initiative.
In many cases it is advisable to apply the same measures within a product group. As a matter of principle, you should consider during the planning phase from which sources you can obtain data on your device or how you can generate them.
In summary, you need a good process and trained personnel who can create meaningful PMS and PMCF plans. You can also keep the effort as low as possible and still achieve maximum output.
What should you start with?
Let us assume that you have decided to revise your PMS process according to MDR or IVDR. What should you start with?
PMS under the new regulations is not fundamentally new. There are some differences in the reports to be produced, but the basic steps are the same.
It is often useful to attend a training course before taking all these steps. Let an expert explain to you what post-market surveillance is about and what steps are necessary. If you now start to familiarise yourself with the subject, it will be much easier for you.
Build up a basic understanding
That's easy for you to say. The topic is complex, there are many ambiguities and it is indeed regularly suggested that PMS is becoming very challenging, especially under the MDR and IVDR. How should one concentrate on the essentials?
We will 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 used, for example, by physicians to treat patients.
- You want to find out whether these products work on the market as you intend them to.
- You are making a plan to take a structured approach.
- In your planning, you consider how you can obtain data on your product and its use in the market.
- Then you collect this data from the planned data sources.
- You analyze and evaluate the data.
- Does the data show that there were problems with the product? Then you derive measures, e.g. a consideration of the previously unknown risks in the context of risk management.
- Now you create a report on the activities.
Congratulations, you have just carried out post-marketing surveillance for one of your products!
In reality, there are of course a number of other aspects to consider, especially with regard to the MDR and IVDR. By and large, however, PMS works just as well if you perform the above steps regularly, ensuring that available data is collected, evaluated, and used regularly.
Post-market clinical follow-up (PMCF) will be discussed in more detail in a future article. Until then, please do not worry: PMCF is not that bad. You just need to know how to do it.
See you for the next article!