The European requirements for medical devices are developed to allow European citizens to have access to safe, effective, and innovative devices. The most efficient way to do this is by giving the manufacturers of devices the authority to place devices on the Union market. There is no system of market authorization as we see for medicinal products. It is the manufacturer who assesses the conformity of their devices, a notified body essentially verifies if that assessment has been done adequately. The authorities only allow their citizens to be exposed to these devices if the manufacturer keeps monitoring their safety and performance while they are being used. This process of monitoring based on real-life data is called post-market surveillance (PMS).
The Medical Devices Regulation (EU) 2017/745 (MDR) requires manufacturers to establish and maintain a PMS system as part of their quality management system. Post-market clinical follow-up (PMCF) is part of PMS. The concepts of PMS and PMCF have already been introduced in the Medical Devices Direct 93/42/EEC (MDD), so this is not a new requirement. However, where the ‘old’ MDD just mentioned PMS, is the ‘new’ MDR requiring certain results to demonstrate PMS has been implemented
The clinical evaluation, laid down in the Clinical Evaluation Report (CER), answers one question: are the risks and side effects of a device acceptable, when weight against the clinical benefits? In order to answer that question the risks must be understood and managed and it must be clear what the clinical benefits are. Although the CER must be based on high-quality data, there will always be assumptions about the likelihood of risks, the harm potentially caused, and the performance of the device. And then there are always the unknown risks that risk management has not addressed. This course sets out how PMS and PMCF are intended to do just that; monitoring risks and performance in real life.
This one-day Masterclass on Mastering Post-Market Surveillance (PMS) for Medical Devices will be presented by Ronald Boumans, who has worked for more than 11 years for the Dutch competent authority, where he was involved in market surveillance. He has seen companies getting into serious problems after missing signals from PMS or PMCF. This course is about developing a skill, rather than transferring knowledge. Participants will learn from real-life examples and they are invited to dive into challenging scenarios.
Companies that managed to become MDR certified want to keep thatcertificate. PMS data can be used to demonstrate continuous conformity.This training helps to increase the quality of PMS data.
Well-performed PMS helps to identify new or changed risks early on. This will allow for more time to make corrections.
PMS can help you understand your competitors and the market you are in. It can drive product development.
This training will deepen your understanding of how all the nuts and bolts in the regulatory machine work together. It will help you in taking strategic decisions.
This training will change PMS from a dreaded burden into an interesting challenge, creating more job satisfaction.
This will help you develop data management strategies whilst creating a PMCF Plan.
In 2022 Ronald started his own consulting service, where he helps companies solve complex problems, working as a PRRC, and training and teaching PRRCs. As such he is a board member of TEAM PRRC, the stakeholder organization of PRRCs. Before this, he worked for Emergo, a global consulting organization. On behalf of Emergo he was a board member of the EAAR, the European Association of Authorized Representatives. He has a wide experience in strategic MDR compliance consulting. He also helps companies find a suitable notified body and he is a borderline and classification expert. He has also been involved in the development of EUDAMED.
Before working for Emergo, Ronald was a Senior Inspector at the IGZ, the competent authority for medical devices in The Netherlands. As an inspector, he has been involved in routine inspections of manufacturers of medical devices and IVDs. He has worked on many market surveillance cases and on projects in which technical documentation of a cohort of manufacturers was linked to actual market experience in hospitals or other environments. He has represented The Netherlands in several working groups of the European Commission, like the Medical Devices Expert Group on Borderline and Classification (MDEG), the Compliance and Enforcement (COEN) working group, and EUDAMED. He has worked for the IGZ for more than 11 years.
Prior to that, he worked for six years in research into the relationship between the use of medical devices and quality of life, for some years even for an organization that also worked as a notified body. In that capacity, he was also involved in developing a test for an ISO standard, which added an unexpected dimension to the ways one may look at medical devices. Before that, he worked in the industry, first in R&D of medical devices and then in import and distribution.
It is safe to say that Ronald has been involved in almost all aspects of the medical devices life cycle and he has been in the eye of the storm of several high-profile cases. In short, he has seen it all (almost).
Ronald compares Regulatory work with flying a plane: a good pilot can land his plane in a storm; an excellent pilot does not end up in bad weather. This summarizes well how he likes to navigate on behalf of the clients he works with.