Understanding the Post-Market Surveillance Process

What you need to know for your Post-Market Surveillance (PMS) Process

Post-Market Surveillance (PMS) one of the key obligations in the EU MDR which came into effect in May 2021. It is also one of the topics which must  be called out for monitoring by the Person Responsible for Regulatory Compliance (PRRC). Specific expectations for manufacturers' PMS system are set out in the MDR's new Article 83. Among other things, the PMS system should be used to update the clinical evaluation, update the benefit-risk determination, update the instructions for use, as well as the labelling. Learn more about the PMS process in this infographic, including crucial steps such as: 

• Developing a medical device
• Conducting the Initial clinical evaluation / conformity assessment
• Placing a device on the market
• Managing device surveillance in the market
• Updating the clinical evaluation report / risk management
• Deciding on necessary measures

We're curious to see what the coming year will bring for MedTech and hope that you will enjoy this infographic. If you have any questions or feedback, please feel free to contact us at hello@climedo.de.

About Climedo Health

Climedo Health’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions.
Together with Europe’s leading hospitals, they have developed a cloud-based platform for cutting-edge clinical validation of medical devices and pharmaceutical products. By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals and patients), Climedo allows for increased performance, better cost-efficiencies - and ultimately - accelerated medical innovation. Learn more: www.climedo.com.