Post market surveillance PMCF

As a medical device manufacturer and as a medical device startup, your responsibilities don’t end when your orthopedic or other medical device product innovation launches on the market. In the EU for example, you must keep an eye on the product for as long as it is on the market according to various (MDR) regulations.

You have a great innovation for a medical device. Now, what are the first steps to take apart from getting investors on board and raise funding? Think about realising post market surveillance (PMCF) from the project start and the feasibility of commercial succes greatly improves. BAAT has the experience and know-how to manage and service all requirements that medical startups encounter. This includes the manufacturing route, CE/FDA application but PMCF as well. You focus on marketing and sales (and getting investors on board) and let us take away the pains that come with ensuring traceability of medical device innovations. Get ready for launch without headaches and hurdles that will come your way. Read all about do’s and don’ts concerning (post) market surveillance and feel free to contact us to get more info on how to move your project forward sustainably.

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Post Market Surveillance PMCF schematic for medical devices

Post Market Surveillance

When a medical device enters the market, the post market surveillance or pmfc plan comes into action. Usually, this includes regular assessment of sales numbers, customer feedback, complaints, incidents and tracking of new/revised laws, regulations and standards. Risk management, Clinical evaluation, technical documentation and the PMS plan are updated with this new information to keep the technical file state of art. In addition, a post market clinical follow up evaluates the safety and performance of the device. Based on this, the manufacturer regularly confirms that the risk-benefit profile of the medical device is favourable and the product can continue to improve the lives of patients.

Post Market Surveillance as a service

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PMCF Legal Manufacturer

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Innovate

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How do you know which ideas are successful in the future? And how do you engineer your medical device to be commercially successful? By asking the right questions with our medical engineers, we find out together how to maximize your impact.

R & D

We can develop your product

How to meet post market device specifications? And what regulatory pmcf quality checks should be taken into account? We know all about design, post market clinical follow up and control and understand what is needed to pass the MDR regulations.

Operations

We can supply your product

How to meet increasing requirements for post market surveillance? We streamline operations, ensure PMCF traceability and handle post market operations and clinical follow-up.

Legal Manufacturer

We can take responsibility for your
product

How to comply with the ever increasing demands from notified bodies? We take responsibility and can be your legal manufacturer even after your medical innovation has entered the market. Post market surveillance as a service.

How do you know which ideas are successful in the future? And how do you control your medical device PMCF to be commercially successful? By asking the right questions with our medical engineers, we find out together how to maximize your impact.

How to meet post market device specifications? And what regulatory pmcf quality checks should be taken into account? We know all about design, post market clinical follow up and control and understand what is needed to pass the MDR regulations.

How to meet increasing requirements for post market surveillance? We streamline operations, ensure PMCF traceability and handle post market operations and clinical follow-up.

How to comply with the ever increasing demands from notified bodies? We take responsibility and can be your legal manufacturer even after your medical innovation has entered the market. Post market surveillance as a service. 

Post Market Surveillance clinical follow up arthrosafe example

Post Market Clinical Follow up

Post market clinical follow up is part of the post market surveillance process, specifically the part that keeps the clinical safety and performance profile of a medical device up to date. Like the post market surveillance, it already starts with a post market surveillance plan (PMCF plan) in the development phase. The goals of a medical device PMCF are to:

  • confirm the safety and performance of the medical device
  • identify unknown side-effects
  • identify emerging risks
  • identify systematic misuse and off-label use

Pmcf plan reporting

The post market clinical follow up plan describes when, where and how to systematically gather information to address these topics.

Once the medical device is being used, the activities in the plan are executed. Our clinical research experts dive into registers, perform critical literature reviews, and assess user feedback. Depending on the risks and unknowns of the device, the PMCF can include post market registry studies and/or post-market clinical investigations with the medical device.

The results are used in the post market surveillance to assess the risk-benefit profile of the medical device and confirm that you can continue selling it. Risk management, Clinical evaluation, technical documentation and the PMS plan are updated with this new information to keep the technical file state of art.

Pmcf plan results

The results and conclusion of the post market surveillance are written down in a periodic safety update report (PSUR); this report is created periodically for the lifetime of the device. Depending on the classification of the device there is a requirement to add this to the technical documentation regularly, at least annually, or even to submit it at the notified body for review each year.

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Post Market Surveillance clinical follow up arthrosafe example
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Baat Medical has made my idea come true. It really contributes to better care for the patient, and to the convenience of surgeons. It's great to work together to realize a medical innovation. I can recommend Baat 100% to surgeons and hospitals that really want to make a move.

Safety of Implantable Devices and Class III devices

For implantable devices and class III devices, information about the safety and performance must be available to everybody. As legal manufacturer you must create a summary of safety and clinical performance (SSCP) and submit it to the notified body. The notified body reviews and uploads it in a publicly accessible database (Eudamed).

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