Post CE mark FAQ
Q: What do you need to do after obtaining the CE mark for your medical device?
A: After obtaining the CE mark for your medical device, several responsibilities and obligations come into play, including continuous quality management system audits, updating documentation, and ensuring compliance with EU regulations.
Q: What are the general obligations for medical device manufacturers (according to EU MDR and IVDR)?
A: The general obligations for manufacturers include implementing Unique Device Identifiers (UDI), appointing Economic Operators and a Person Responsible for Regulatory Compliance (PRRC), and updating labelling and device documents to comply with language requirements. Additionally, maintaining a compliant Quality Management System (QMS) is essential.
Q: Why is risk management needed in post-CE mark activities for medical devices?
A: Proper risk management post-CE mark can reduce Field Safety Corrective Actions (FSCA) and ensure the safety of device users. It involves continuously evaluating and addressing risks associated with device use, adhering to state-of-the-art measures, and ensuring the effectiveness of risk mitigation measures throughout the device’s lifecycle.
Q: What is the significance of continuous risk management according to the MDR?
A: Continuous risk management is essential as per the MDR, requiring regular updates and evaluations throughout the device’s lifecycle. It involves collecting relevant data from various sources and assessing any changes in risks, benefits, or other factors affecting device safety and performance.
Q: What is involved in updating Clinical Evaluation Reports (CERs) post-CE mark?
A: Manufacturers must routinely update CERs throughout the device’s lifetime, typically every 1-5 years, depending on risk class and device establishment. Updates are necessary to incorporate new information affecting the device’s risk-benefit profile, ensuring compliance with regulatory requirements.
Q: How does Post Market Surveillance (PMS) help ensure device safety and performance post-CE mark?
A: PMS involves collecting data on device safety and performance continuously. Manufacturers need to set up proactive and systematic processes to gather information, including both reactive (responding to events) and proactive (preventive measures) approaches.
Q: What are the requirements for Post Market Clinical Follow-Up (PMCF) studies post-CE mark?
A: PMCF studies may be necessary to address gaps in clinical data not covered by routine surveillance. Manufacturers must plan and conduct PMCF studies as needed, providing periodic updates to ensure ongoing compliance with regulatory requirements.
Q: How does vigilance reporting contribute to post-market surveillance?
A: Vigilance reporting involves identifying, reporting, and addressing serious incidents related to device safety. Manufacturers must report incidents to competent authorities within specified timeframes, ensuring prompt actions to mitigate risks and maintain device safety.
Q: What is involved in updating Technical Documentation post-CE mark?
A: Technical Documentation must be continuously updated to reflect changes in device manufacturing and regulatory requirements. Manufacturers should conduct regular audits and maintain records of documentation for at least 10 years after placing the product on the market.
Risk Management
Effective Post Market Surveillance
