One of the biggest challenges during MDR transition is to understand what brings new regulation to post market surveillance requirements.
Click here for the full Medical Device Regulation (MDR 2017/745).
In our daily life, if we want to improve our work, we listen to other people’s opinions and then make a decision and take action. So “Market Surveillance” is the same thought. We manufacture a product. We release it to the market and then we collect other people’s opinions. With these datas, we develop our products and maintain their safety.
I think every one of us knows and follows “Post Market Surveillance” system. But how? For example, during a medical exhibition or a congress, people are talking to us and tell good or bad things about our products. If we tend to develop our products and aim to have fewer complaints about our products, we take these criticisms into account. These criticisms help us to understand where we are wrong and where we are safe.
But how many of these criticisms do we record? What are we doing to collect these criticisms systematically? This chapter shows us how to prepare a plan and collect datas for a sustainable post market surveillance system.
In this blog, we’ll try to explain which paragraph what tells us.
1
For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer’s quality management system referred to in Article 10(9).
Regulation gives us a space according to our devices’ risk class. But it does not mean that we don’t care the surveillance if we have a product which has lower class. It means that if we have a product which has a higher class, we should pay more attention.
Other important word is “update” in this paragraph. A specific time frame should be determined for data collection and then these datas should be reviewed and documented. For example, a year can be splitted into 4 periods and it can be determined which data is collected during these periods. It should be determined in which periods the data is processed.
2
The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.
The important word is here “lifetime”. This paragraph does not allow us to collect the data only for lifetime of the device. Imagine that you have a electrical medical device and according to your design tests, this device has 7 years of lifetime. It does not mean that you finish collecting data after 7 years. You will be collecting the data forever until not one of these devices is left in the market. These collected data will also enable you to reach the real lifetime of your device.
3
Data gathered by the manufacturer’s post-market surveillance system shall in particular be used:
(a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
(b) to update the design and manufacturing information, the instructions for use and the labelling;
(c) to update the clinical evaluation;
(d) to update the summary of safety and clinical performance referred to in Article 32;
(e) for the identification of needs for preventive, corrective or field safety corrective action;
(f) for the identification of options to improve the usability, performance and safety of the device;
(g) when relevant, to contribute to the post-market surveillance of other devices; and
(h) to detect and report trends in accordance with Article 88.
The technical documentation shall be updated accordingly
What you should do with this data?
a) There are always unknown risks. It is used to eliminate these risks.
b) The more you collect information from users and update your instructions and labels, the safer and more practical use you will provide to your users.
c) The data you collect will also be used scientifically.
d) In addition to developping the product, you will be sure of the safety of your product.
e) As you will increase communication with the users during data collection, you will approach the problems that occur in the field with more systematic solutions.
f) For example, 85 percent of your users stated that they always keep their electrical medical device turned off when they are not using it, while 15 percent stated that they leave the device on throughout the day even if they do not use the device. You saw that while the devices of the users in the first group needed less service, the devices of the users in the second group needed service more frequently. This will be a significant data which affects directly the performance of your device.
g) You manufacture a orthopedic saw and a single-use saw blade for this active device. These devices are 100 percent connected to each other. During data collection, you saw that your orthopedic saws started to malfunction frequently for a period. When you deepened your research, you saw that because of the cost, disposable blades were used more than once, which damaged the these orthopedic saws. In the light of these developments, you can redesign your blades to be used more than once, and you can both find a solution to the needs of the users and reduce the safety risks in your orthopedics saws.
4
If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87.
Being a communication with the users of your devices will helps you to solve the problems fast. You will take preventive or corrective actions as fast as you can and inform other authorities.
a) The post-market surveillance plan shall address the collection and utilization of available information, in particular:
— information concerning serious incidents, including information from PSURs, and field safety corrective actions;
— records referring to non-serious incidents and data on any undesirable side-effects;
— information from trend reporting;
— relevant specialist or technical literature, databases and/or registers;
— information, including feedbacks and complaints, provided by users, distributors and importers; and
— publicly available information about similar medical devices.
You need to collect all the above data and explain in the plan how you will analyze it. If you don’t have any data for your medical devices, you can collect the data of similar medical devices and you can connect them.
For example, a serious incident has never happened for your device. But when you do some research, you learned that there are a few serious incidents on devices similar to yours or you have seen that no serious incident has ever occurred on devices similar to yours.
You should mention in the plan that you will also collect and process information similar to your device, and that you will take precautions or actions by linking this information together.
Read the “MDR Vigilance Requirements – Reporting of Serious Incidents” article, to learn what is serious incident, how to report it and reach a report template.
(b) The post-market surveillance plan shall cover at least:
— a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
— effective and appropriate methods and processes to assess the collected data;
— suitable indicators and threshold values that shall be used in the continuous reassessment of the benefitrisk analysis and of the risk management as referred to in Section 3 of Annex I;
— effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
— methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
— methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
— reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
— systematic procedures to identify and initiate appropriate measures including corrective actions;
— effective tools to trace and identify devices for which corrective actions might be necessary; and
— a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
-The word “proactive” means: Creating or controlling a situation rather than just responding to it after it has happened.
-You need to explain how you will use the data you collect. For example, 80 percent of the 50 users you interviewed stated that the interface of your device is very complex and difficult to use. If it is determined that there is a difficulty in the use of the device as a result of the collected data, you should plan that the user manuals will be updated and more training will be provided to the users.
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