The Ins and Outs of Post Market Surveillance Under the EU MDR – Webinar Transcript – Part 1

Joseph-Richardson Larbi has 18 years of experience in Medical Device (MD & IVD) Regulatory and Quality strategies (from design development to market launch and post marketing activities – compliant to MDD/MDR/IVDR/ISO 13485/9001 Quality Management Systems). He is experienced in MD CE certification, ISO 14971 Risk Management, Manufacturing and Supplier Management, Manufacturing Verification and Validation, Post Market Surveillance, Clinical Evaluation Reports, Drug Device Combinations, regulatory relationship management, and has advanced knowledge of FDA Drugs, Biologics, and Biosimilars (IND, NDA, BLA).

Expanded Post Market Surveillance (PMS) requirements is a major hurdle that the EU MDR presents. Notified Bodies will be expecting a far greater amount of Post Market Surveillance data, and device manufacturers must improve their PMS systems and processes to adapt.

During our webinar titled “The Ins and Outs of Post Market Surveillance Under the EU MDR,” Joseph spoke specifically about why the expanded Post Market Surveillance (PMS) requirements are a major hurdle that the EU MDR presents.

Why should you read the transcript / watch this video?

• To better understand the MDR requirements for PMS
• Learn about the purpose of PMS in the EU MDR
• For an explanation of Article 83 and Article 84 of PMS

A full transcript of Joseph’s presentation is available to download (and to read below) and just press play to watch the clip now. 

The requirements are stated in articles 83-92 of the MDR. These are specifically tied to post-market surveillance, and going through every article, it tells you what you need to do. Let’s start with article 83, which defines the PMS system that you must have in place and what you’re going to do about it. The PMS system is actually driven by your PMS plan. Your PMS plan is stated in article 84, or Annex III. The Annexes will tell you how you should put things together, whilst your articles tell you what you need to do. So, the articles will tell you what to do, but they won’t tell you how, but the Annexes will tell you how or what exactly should be reported into your particular document or report.

Your PMS plan, which drives the system, is the plan that will detail the methods that you’re going to use to collect your data, or what are you going to collect, the frequency, and how you will communicate.

The PMS plan should be part of your technical documentation that you will be submitting initially for your conformity assessment to your notified body, and for your technical documentation that is stated in Annex II. To summarize:

• Article 85 – Post Market Reports for Class 1
• Article 86 – PSUR Periodic Summary Update Report with a Safety Update Report
• Article 87 – Serious incidents and Field Safety Corrective Action Reporting
• Article 88 – Trend reports – how you analyze the trends, what triggers did you put in place, and what systems you are actually using to analyze the data of your medical device
• Article 89 – This talks about how you’re going to analyze these reports both from a manufacturer’s point of view and from the competent authority and the European Commission’s perspective

We should all bear in mind that the MDR came as a result of heavy criticism that was alleged against the MDD framework and the key parties involved. So now, competent authorities are supposed to carry out a detailed analysis of vigilance, analysis of reports that manufacturers or notified bodies have submitted to the electronic system, and that the system is aligned with what is defined in article 92 – the EUDAMED – the European Database for Medical Devices.

Article 92 branches off into article 90, which talks about the competent authorities and the analysis that they will be doing. The member states or the competent authorities will have to work with the European Commission when they’re doing extra analysis as well. Then the competent authorities will be assessing article 92, which is the data that has been submitted by the manufacturer into EUDAMED. Competent authorities can then say, let’s analyze a particular wound care dressing device that we’ve got reports of in France, and the trend in the report is not looking good. France could then ask a German colleague how this device performs on their market. Many items are not covered in articles 83 to 92, you’ve also got your quality management systems with its SOPs, your risk management system, your clinical evaluation plans, and reports (CER) and your post-market clinical follow-up plans and reports (PMCF) and then your summary of safety and clinical performance of your devices (SSCP).

Article 83 describes what you must have in a post-market surveillance system, and this should be established and maintained. The PMS should be part of your quality management system. You must have processes already identified, defined, and written readily available to demonstrate what you are going to do. The key processes that you’re going to have to do will depend on your device classification.

Your PMS system is risk class dependent. It must be suited to the activities that you’re doing, and it must systematically gather, record, and analyze the data that you’re going to capture. It must also define what sort of data that you’re going to capture, and the data should be able to cover the quality, performance, and safety of your device throughout its life cycle. It’s not just the first two years of putting the products onto the markets, it’s for the entire lifetime. For some of these reports you have to do that manually, and for some of these reports, you have to submit them every two years. For some of them, you have to go according to your notified body audit schedule.

The plan that you put in place must be able to achieve all the things that you have defined as what you’re going to do in your PMS system, and the PMS system must power your QMS. All these things are linked together now. Your QMS defines your PMS system, and your PMS system has got the PMS plan. They are all integrated and your PMS plan must be part of your technical documentation.

Why is it part of your technical documentation? Your notified body that’s assessing your products wants to know what you’re going to do to maintain the products to continue to be compliant to the MDR, or whatever standards that you are following to make sure that you are putting processes in place. Also, they want to make sure you are actually going to follow these and that the device is going to be compliant and most importantly, users are going to be safe. Additionally, to prove your benefits do outweigh your risks. That’s why it will give you the approval or CE Mark. But when it’s widely used, what does this benefit risk ratio look like after millions of people have actually used your device?

What methods are you going to use to gather this data? If you’re going to analyze scientific literature, what databases are you going to assess? PubMed or Embase, all these scientific and digitized databases are out there. How are you going to analyze your data? What methods are you going to deploy your methodology to analyze the data? All of these things must be stated in your PMS plan, which is part of your QMS, and you must have your SOPs.

The most important thing here is that the PMS plan must identify your PMCF plan. Post-market clinical follow-up is the heart of your post-market surveillance and there’s a big emphasis on post-market clinical follow-up for medical devices under the EU MDR. Basically, for your post-market clinical follow-up, when you are going to market you might have very little clinical data on the use of the device. But now that it’s been widely used, how is it performing? What’s the safety and performance of it, the side effects that you identified pre-market stage, how are they holding up? Are you seeing a bigger ratio or lesser, the contra indications that you stated – how are they doing?

So you will have a list of objective things that you want to achieve, and some of them could cost a lot of money. It’s advisable to space these things out over a period of time. Don’t just go in year one trying to achieve everything. It is acceptable if you decide to spread out some of these activities over a five-year period. For example, in year 1, this is what you’re going to cover, year 2, this is what we’re going to cover as your objective, etc. Then basically feed in your risk elements from the pre-market stage with the data that you’ve gathered in your post-market stage and reevaluate things. That’s a general summary of your post-market clinical follow-up.